As leaders in the
industry, Jurak Corporation World Wide Inc. developed the “Shares for
Distributors” plan in which we make publicly traded shares available to our
distributors.
Below,
we quote a letter written to our Securities Attorney at the time Jurak
Corporation World Wide Inc. was applying to the Securities Exchange Commission
to become a public traded company. It was written by our FDA Consultant, William
D. Appler, M.A. of Regulatory Strategies Consultants, Washington, DC and San
Francisco, CA
March 4,
1999
Charles Clayton, Esquire
527 Marquette
Minneapolis, MN 55402
Re: SEC Review of Jurak Corp. WWI
Response to SEC Letter January 19, 1999
File No. 333-61801
Dear
Mr. Clayton:
This letter responds to your request that we draft a response to the SEC's
letter of January 19, 1999, regarding the regulatory status of the company's
Jurak Classic Whole Body Tonic. This request included general inquiries about
the regulatory authority of the Food and Drug Administration (FDA), and Federal
Trade Commission (FTC), over dietary supplements such as Jurak's Tonic (Question
5), and specific questions seeking information for some of the statements made
about this product. (Questions 1-4, 6).
As an initial matter, we believe that most of these requests are unnecessary.
For example, in Question 4, the SEC seeks information which the FDA is barred,
by law, from obtaining from a distributor of dietary supplements (see discussion
below). Other questions contain errors of fact, such as the statement that "the
Dietary Supplement Health and Education Act of 1994 ...goes into effect in
March, 1999" (in fact, the law has been in effect since October, 1994). Finally,
the request to determine (Question 6) "the primary ingredients of your product
... and the effect of those ingredients" is inappropriate, because Tonics do not
have "primary ingredients"; by definition, all the ingredients work together,
and it would be speculative to discuss "the effects of those (primary)
ingredients."
Thus, we fail to see the relevance of these FDA-issue questions upon the
company's power to issue stock. However, we respond to them below, as best we
can: first, we respond to the general question 5, and then to the more focused
product issues in the remaining questions.
5. Describe the regulations with which you must comply as distributor of dietary supplements. Include in this discussion an overview of the Federal Trade Commission's role in regulating dietary supplements, and describe the material legislation with which you must comply. Disclose whether you are currently in compliance with the Dietary Supplement Health and Education Act of 1994, which goes into effect in March, 1999, and discuss the material provisions of that Act.
a. Since 1938, Congress has divided regulatory authority over all food products, including dietary supplements, between the FDA and the FTC. The FDA has the more substantive authority: review of ingredients and safety, defining and punishing misbranding, and defining and punishing adulteration. FTC's jurisdiction is limited to claims made in advertising and promotional materials, including television and radio advertisements. 1/ JCWWI is a multi-level distributor, and does not advertise, nor issue promotional materials, so its activities are not regulated by the FTC, but only by FDA.
b. FDA has general statutory authority over all food products (21 U.S.C. 342, 343) to prohibit the introduction into interstate commerce of adulterated or misbranded products. In addition, the agency has issued comprehensive general food labeling regulations (21 C.F.R. Part 101), requiring that all food packaging contain the product's name, quantity of contents, ingredients and nutritional labeling, and name and address of the manufacturer, importer or distributor. Finally, FDA has issued Good Manufacturing Practices for foods (21 C.F.R. Part 110), though not as yet for dietary supplements.
--containing a poisonous or deleterious substance including an approved food or color additive, a filthy or putrid ingredient, or has been stored under unsanitary conditions. (21 U.S.C. 342 (a) - (c).
Likewise, food product labeling may amount to misbranding for a number of violations, but the most common ones are:
--false or misleading labeling, misleading container fill, or violations of the labeling regulations (21 U.S.C. 343).
Finally, the labeling regulations are fairly straightforward, and it has long been FDA's policy that if a label is violative, the manufacturer may correct it when he next reprints the label, unless the violation raises safety issues (i.e., fails to include an ingredient to which consumers may be allergic, i.e., tree nuts, some color additives).
1/ (The text of this footnote is provided at the end of this section of our letter, and is at the bottom of page eleven of the text.)
The only moderately complex provisions of the labeling regulations are those dealing with serving sizes and mandatory nutritional labeling. However, these regulations do not apply to dietary supplements which - -effective March 23, 1999, subject to small package and small company exemptions -- will be subject to special Supplement Facts labeling.
c. Congress substantially modified the rules governing dietary supplements when it enacted the Dietary Supplement Health and Education Act of 1994. Its goal was to limit and control FDA's powers over dietary supplements, because Congress perceived that the agency had been acting unreasonably in regulating these products. 2/ Except for Section 7, all of DSHEA became effective when it was passed in October, 1994, and has been the law since then (contrary to the assertion in Question 5).
The focus of DSHEA has been to limit FDA's authority to regulate dietary supplements, because of Congressional concern that consumers have access to these important health products. In Section 2 of DSHEA, Congress articulated the principles that motivated it to provide such extensive protection to the dietary supplement industry. Congress found, as facts, that:
"{T}he benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies";
"There is a link between the ingestion of certain nutrients and dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis";
"Preventive health measures, including . . . appropriate use of safe nutritional supplements, will limit the incident of chronic diseases, and reduce long-term health care expenditures";
"Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements";
"Dietary supplement are safe within a broad range of intake, and safety problems with supplements are relatively rare."
2/ For example, FDA classified most dietary supplements, incorrectly as food additives, which require preclearance before they can be used. In one case, FDA said the single dietary supplement was "added" to its gelatin capsule. The courts threw this interpretation of FDA's out, shortly before DSHEA expressly stated that dietary supplements were not food additives.
Congress then turned, in Section 2 of DSHEA, to emphasizing that the intent of this statute was to limit or prevent arbitrary FDA regulatory action against dietary supplements:
". . . the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers";
"A rational Federal framework must be established to supercede the current ad hoc, patchwork regulatory policy on dietary supplements"; and
"Legislative action that protects the right of access of consumers to safe dietary supplements is necessary. . ."
DSHEA's substantive provisions mirror the Congressional intention to "remove unreasonable {FDA} regulatory barriers" to disseminating "safe products and accurate information"; supercede the current ad hoc" FDA policy hostile to dietary supplements; and protect "access...to safe dietary supplements". DSHEA does not so much impose regulatory obligations upon the supplement industry, as impose limitations on FDA's regulation of it.
Section 3. DSHEA permits dietary supplements to be marketed as conventional tablets and pills, etc., but it also allows these products in the form of bars, beverage and other forms resembling conventional foods, so long as they are not marketed as foods. Previously, FDA had not permitted the latter uses. Supplements are broadly defined to include any "substance for use by man to supplement the diet by increasing the total dietary intake". DSHEA, 3.
Section 4. DSHEA defines harm or "risk" in connection with a dietary supplement very favorably to the industry. First, the initial barrier is set high: a dietary supplement product is adulterated only if it includes an ingredient "that presents a significant or unreasonable risk . . ." Second, that risk must exist "under conditions of use recommended or suggested in the labeling"' products which might be dangerous if over consumed are not adulterated under DSHEA. Third, DSHEA removes any FDA authority to take a product or class of products off the market, regardless of their supposed risk. This right is reserved to the Secretary of HHS, and it "shall not be delegated" to FDA.
DSHEA also places the "Burden of Proof on FDA" on all enforcement actions, a reversal of long-time judicial policy. It likewise protects dietary supplements from enforcement actions to an extent unknown to all other FDA-regulated products. For example, FDA may immediately seize, or file an injunction action against, all conventional foods and food additives, prescription and OTC drugs, biologicals, medical devices, cosmetics, and animal foods; however, under Section 4 of DSHEA, FDA must give the dietary supplement manufacturer "at least 10 days . . . notice", and an opportunity to be heard, before referring any enforcement matter to the Department of Justice.
Section 5. This section of DSHEA carves a broad exception out of FDA's long-standing policy, that the use of "third party" promotional material transfers the claims in that material to the product it is used with, thereby misbranding it. Section 5 expressly provides that the use of a "publication . . . in connection with the sale of a dietary supplement . . . shall not be defined as labeling" (and thus be impugned to the product), so long as it is "not false or misleading", "does not promote a particular manufacturer or brad of dietary supplement", "present{s} a balanced view of the available scientific information on a dietary supplement", and does not have any material added to the original publication.
As a result, dietary supplement manufactures may distribute, with their products, articles, scientific literature, and even materials the manufacturer has prepared (such literature need not be "third party"), which contain claims for an ingredient that could not be used on its label, so long as the publication does not mention the company nor the product name. With this provision, dietary supplements enjoy far greater opportunities to promote their products than do any other foods.
Section 6. This section of DSHEA likewise provides to the supplement industry the right to make claims on its products which FDA has previously concluded would misbrand the product.
a. Structure/Function Claims. DSHEA permits a dietary supplement to explain how consumption of the product may "affect the structure or function {of the body} in humans", and/or to describe "general well-being from consumption of a nutrient or dietary ingredient." Such claims typically "describe the role of a nutrient or dietary ingredient intended to affect the structure or function {of the body} in humans", or "characterize the documented mechanism by which a nutrient or dietary ingredients acts to maintain such structure of function". 21 U.S.C. 343 (r) (6) (A), DSHEA 6 (a). If a manufacturer elects to do so, he must comply with three DSHEA requirements:
1) Notification. He must notify FDA within 30 days of first making that claim, providing the agency with the name of the product, the claim, the ingredients, and a certification that the information is not false or misleading;
2) Disclaimer. He must include on the label an "FDA disclaimer", stating that the claim "has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease". For product labeled after March 23, 1999, the disclaimer must appear on every package panel where there is a structure/function claim, including the Principal Display Panel.
3) Substantiation. DSHEA requires that for every structure/function claim, the manufacturer "has substantiation that such statement is truthful and not mislead." However, what qualifies as substantiation, either as to the type or quantity of materials, is not defined in the statute.
FDA has expressly refused to define substantiation, saying that such determinations are entirely up to the manufacturer. Indeed, it was unwilling to give industry guidance on substantiation: "FDA finds no need for it to elaborate on the substantiation standard that appears in the act" (i.e., that a manufacturers must have it). 62 Fed. Reg. at 49884, September 23, 1997.
However, Congress clearly intended that dietary supplement companies' substantiation be something less than the standard for drug claims, i.e., two randomized controlled trials. For that reason, articles, scientific reviews, affidavits from experts, the German Commission E monographs, books and articles, anecdotal evidence, etc., all can constitute substantiation that a claim is not false or misleading.
Finally, Congress did not provide FDA with the right to see a manufacturer's substantiation. See DSHEA, § 6; FD&C Act, passim. To the contrary, FDA's general inspection powers allow the agency to see only such factory, warehouse, establishment or vehicle, and all pertinent equipment, finished and unfinished materials, containers, and labeling therein.
21 U.S.C. 374 (a) (1) (B). FDA's power to see "records, files, papers", etc. applies only to companies which produce "prescription drugs or restricted devices . . ." ,Ibid., and thus does not allow the agency to see substantiation for dietary supplement claims.
b. Drug Claims. Section 6 of DSHEA forbids a dietary supplement manufacturer from making, on his label or in his company's labeling, "a claim to diagnose, treat, cure, or prevent a specific disease or class of diseases." Such "drug" claims misbrand the dietary supplement, and may be subject to FDA sanctions.
Section 7. This section was the only part of DSHEA not effective on passage of the Act; indeed, it is still not effective. However, after March 23, 1999, dietary supplement labels must conform with the provisions of subsections (a) and (b).
(a) Misbranding. A dietary supplement will be misbranded if its label fails to list "the name of each ingredient"; "the quantity of each ingredient"', unless it is a part of a proprietary blend"; and in the case of an herb or botanical, the "part of the plant from which the ingredient is derived". The label must use the term, "dietary supplement", and the product must meet any claims it makes regarding its strength, purity, etc.
FDA's final dietary supplement labeling requirements, provide for nutritional labeling that is largely modeled after that used on conventional foods since the early 1990's. FDA provided numerous examples, showing substance and format, in its final regulation of September 23, 1997.
Minor provisions in Section 7 allow a label statement as to the amount of an ingredient that is not a nutrient, and substitute the term "dietary supplement ingredients" for "vitamins and minerals" at several places in the FD&C Act.
Section 8. This section establishes procedures for FDA's reviewing new dietary ingredients, and ascertaining that they are safe. It has been little used, and JWWCI neither uses any "new" dietary supplement ingredients, nor has it any plans to do so.
Section 9. Section 9 defines as adulterated any dietary supplement that is manufactured in violation of Good Manufacturing Practices adopted by FDA. Part (2) of Section 9 authorizes FDA to issue GMP's, so long as they are technologically feasible for the industry to meet. To date, FDA has published in the Federal Register (February, 1998) the industry's GMP proposals. But it has not published an agency proposal, and final dietary supplement GMP's still appear to be years away.
(The remaining few sections of DSHEA are not of substantive importance.)
SUMMARY. To comply with DSHEA, a dietary supplement manufacturer must:
JCWWI is currently in full conformance with this requirement. The Principal Display Panel for the product states: "Jurak Classic Whole Body Tonic", followed immediately by the words: "Dietary Supplement", with no intervening written or graphic materials. The type size for the words "Dietary Supplement" are the same size as the letters used in "Whole Body Tonic".
The product fully complies with this requirement. Each of the eighteen herbal ingredients is widely used in a variety of other single use and blended herbal products, and none of them has been implicated in any safety-related concerns. The product as labeled for consumption (1 oz. Daily dose) could not possibly be expected to pose a "substantial" or an "unreasonable" risk to health. No such claims have ever been made against this Tonic.
JCWWI has not prepared, nor used, any Section 5 literature, and has no present intention to produce nor use such literature. If it does so, all such publications will comply with these requirements of Section 5.
JCWWI is fully in compliance with each of these requirements of Section 4 of DSHEA. First, while the only claim on the label or in the labeling is that Jurak Classic is a "Whole Body Tonic", and a "corrective and Digestive Herbal and Mineral Supplement" - - neither of which identifies any structure or function of the body for which a claim is being made - - JCWWI nonetheless submitted a notice to the FDA that it was going to market this product. Its notice complied entirely with 21 C.F.R. 101.93, and was filed in advance of the time for filing specified under that regulation. FDA did not object to these claims.
Second, following the claim, a "Corrective and Digestive Herbal and Mineral Supplement", and on the same panel of the box where that claim appears, JCWWI has included a boxed, bold-faced statement: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, mitigate or prevent disease".
Third, there is abundant substantiation for the claim that Jurak Classic is a "Whole Body Tonic", or a "Corrective and Digestive Herbal and Mineral Supplement." This substantiation, which is discussed more fully in the next section, includes one or more of the categories of scientific support, for each of the 22 herbal and mineral ingredients:
a. Submission of a claim for the ingredient to FDA, and FDA's raising no objection to it;
b. Inclusion as effective in the German Herbal Monograph program, Commission E;
c. Inclusion as an herbal ingredient substantiated for effectiveness by the independent Herb Research Foundation;
d. Included in research materials demonstrating effectiveness issued by the independent scientific organization, the American Botanical Council;
e. Analyzed and discussed in numerous scientific books and articles.
f. For purposes of this letter, independently reviewed by expert herbalists on the east and west coast, both of whom concluded that these ingredients are effective for supporting a variety of bodily systems.
g. The herbal ingredients in the Whole Body Tonic are listed as effective for their numerous indications in the Physician's Desk Reference for Herbal Medicines.
FDA has refused to define a substantiation, either as to type of material or as to quantity. Substantiation is thus left up to each individual company. However, it is clear that Congress did not intend that dietary supplements meet clinical trial requirements necessary for prescription drugs. FDA has never argued that clinical trials are necessary to substantiate DSHEA claims (nor has the FTC made any such argument in its recently issued advertising guidelines, FN.1).
There is ample substantiation that the herbal and mineral ingredients in the Whole Body Tonic are effective as a Tonic to sustain good health.
5. Effective March 23, 1999, the labeling of a dietary Supplement must contain the name and amount of each ingredient, the part of the plant from which any herb or botanical ingredient comes, the Latin name of each herb or botanical (unless that name is listed in "Herbs of Commerce"), the words, "Dietary Supplement" or "Supplement", and meet any specification for which it is represented.
Months before the March 23, 1999, deadline date, the labeling for Jurak Classic Whole Body Tonic included the Latin name, plant part, and other DSHEA requirements. ("Dietary Supplement" as part of the product name). It's label more than complies with the law; for example, Latin names for the ingredients are included even where they appear in Herbs of Commerce.
6. Effective March 23, 1999, the label must contain Supplement Facts (nutritional) labeling.
JCWWI complied four months before this was due.
These are the sole DSHEA requirements in effect for dietary supplements, including the one FDA implementing regulation, which becomes effective on march 23, 1999, JCWWI is in full and complete compliance with every one of them, and in several cases, was in compliance before the requirement became effective.
4. Provide us with supplemental support for these statements. We note that you do not have any scientific evidence for these effects. If that is the case, you should indicate that all these statements are your beliefs instead of referring to them as statements of fact. Also, include a risk factor indicating that there is no scientific evidence that supports any of your claims about the efficacy of your products.
It is categorically incorrect that JCWWI has no "scientific evidence of these effects" of the Jurak Classic Whole Body Tonic. A small portion of the scientific substantiation for the product's claims is set forth below.
1/ (From page 2) FDA and the FTC impose substantively different standards upon claims coming within their respective jurisdictions. For example, if a dietary supplement were to contain a "drug claim (i.e., a claim to cure, mitigate, treat or prevent any illness") on its label or in its labeling, then FDA would view the product as a misbranded food or a non-approved drug (or, usually, both). It would be immaterial to the FDA whether or not the claim were true, or whether it were substantiated. If the same claim were made in a newspaper advertisement or a television commercial under FTC jurisdiction, the FTC's inquiry would focus on whether the claim was true, or substantiated. If the same claim were made in a newspaper advertisement or a television commercial under the FTC jurisdiction, the FTC's inquiry would focus on whether the claim was true, or substantiated. If it were, then the FTC would encourage the dissemination of this true information to consumers, while the FDA was perhaps enjoining the company from making this drug claim. Two results have followed since 1938, when the statute divided responsibility for food related matters between these agencies. First, for virtually every FDA food labeling initiative since 1938, FTC has filed comments opposing the FDA proposal, largely because it would prohibit the _expression of some truthful statements. Second, because FTC permits drug claims that have been proven or are "true", its substantiation standards are much higher than the FDA's. Nevertheless, in its recently issued guidelines, "Dietary Supplements: An Advertising Guide for Industry", FTC defined the "competent and reliable scientific evidence" necessary to support an advertising claim as including "tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area . . . " Thus, not even FTC view clinicals as a condition of product substantiation.
A. Jurak Classic Whole Body Tonic.
The leading text on herbal tonics is Daniel B. Mowrey, Ph.D., Herbal Tonic Therapies (Keats, 1993). The author defines a tonic as a combination of herbs "that balances the biochemical and physiological events that comprise bodily systems". A substance which "tends to maintain the optimum" bodily health, or that "moves a system back toward the optimum [healthy]state is a tonic." (p. 4).
Tonic herbs, such as licorice, which the author describes as "one of the best tonic plants in the world" (7), are "free of side effects, and generally free of all contraindications", and are "consumable in small amounts on a daily basis without demonstrating habituation or tolerance" (11). Moreover, "[t]onic herbs are, as a rule, somewhat milder and more delicate in action. . ." (12).
In sum, then, an herbal tonic is a combination of various herbs intended for the "maintenance of normal physiology", and "restor[ing] balance to body systems that are under stress". It does so by including ingredients known to sustain or assist various parts and organ systems of the body. The consumption of herbal tonics is thus a way of "restoring balance and promoting the overall health of the body" (13).
There are dozens and dozens of herbal tonics on the market, most making far more extensive claims than Jurak Classic Whole Body Tonic. FDA has recognized the appropriateness of such dietary supplement products, so long as they do not make drug claims.
For example, on December 7, 1997, a dietary supplement company named the Traveling Herbalist submitted an Energy Builder Tonic to the FDA, as required by DSHEA Section 6. The claim made for the product was that it provided "a daily tonic for whole-body balance". FDA had no objection to this product or claim.
Likewise, the FDA, the federal agency responsible for controlling the product names, claims, safety, adulteration, misbranding and truthfulness or herbal dietary supplement products, expressed no objection when JCWWI registered its product and claims with the agency.
B. Scientific Substantiation.
Alfalfa
1.
FDA did not object to a claim that Alfalfa was Useful in providing "enzymatic
action." Alfalfa has been declared GRAS by FDA (21 C.F.R. 182.10, -.20).
2. Not reviewed by Commission E.
3. The Herb Research Foundation (HRF) concluded that claims for Alfalfa were
substantiated in the scientific literature.
4. The American Botanical Council (ABC) provided articles from the scientific
literature that stated as follows: Alfalfa has been shown to increase excretion
of neutral steroids and bile acids in fecal matter;" and is used in traditional
medicine "to increase vitality, appetite, and weight in humans; also as a
diuretic,
galactogogue, and to increase peristaltic action of the stomach and
bowels . . .
5. Daniel B. Mowrey, Ph.D.,
in The Scientific Validation of Herbal Medicine (Keats,
1986), reports: "Alfalfa's effect is probably due to its extremely high
nutritive value . . .it generally helps to improve overall health, vigor and
vitality. . . Alfalfa is one of the most nutritious foods known. . . Alfalfa is
an appetite stimulant and vitality augmenter . . . As a spring tonic, Alfalfa
has no equal." (2, 91, 291). Similar, but more extensive support, can be found
in the same author's Herbal Tonic Therapies.
Jones, in the Medicinal Herb Handbook reinforces the high nutrient
content of Alfalfa; "This nutritive herb has a high mineral content that is
easily digestible, particularly calcium, vitamin K, and folic acid; stimulates
lactation while increasing the quality of breast milk." (3)
6. For purposes of this letter, we retained two prominent herbalists, one in
Massachusetts and one in Colorado, to review the herbal ingredients in the Jurak
Classic Whole Body Tonic, and assess their probable effect in human beings. Ms.
Joanne Snow of Nature's Answer resides in the east; Mr. David Litell of Chemins
Company resides in the west.
Angelica (Dong Quai)
1. FDA has not objected to claims for Angelica submitted to it pursuant to
DSHEA, including: "promoting women's health and well being"; "female balancer
and tonic"; "help maintain a woman's health and well-being during and after
menopause"; "gives a woman's body the tools it needs to sustain health and well
being through the natural change". FDA has declared Angelica to be GRAS. (21
C.F.R. 182.10,-.20)
2. The German Government has issued a monograph (No.101) finding Angelica root
effective for appetite loss, digestive ailments, and mild gastrointestinal tract
spasm.
3. The Herb Research Foundation has prepared a package of scientific materials
substantiating claims for Angelica.
4. The American Botanical Council reports the following, with each statement
supported by one or more citations to the scientific literature: "Angelica is
considered to have diaphoretic and
expectorant properties. Cardiovascular
effects have also been reported . . . (used also) for menstrual regulation and
as an expectorant . . . Reportedly used in Europe for centuries to treat stomach
troubles caused by indigestion."
5. Mowrey, Herbal Tonic Therapies, reports a number of documented
effects on the body's structure and function with Angelica (Dong Quai): it is
"used medicinally as a tonic, cardio tonic, respiratory tonic and liver tonic .
. . [It] is also often recommended during pregnancy to ease delivery, reduce
pain and discomfort, and eliminate complications as much as possible."
"Dong Quai has smooth muscle relaxing, antibiotic and analgesic properties."
"Studies have shown that Dong Quai is hypotensive through a dilation of blood
vessels." It also "has immune system enhancing properties." (304-307).
Jones, Medicinal Herb Handbook, reports that "Angelica [is] [u]sed
in weak digestion; as an anti-spasmodic, it prevents uterine and intestinal
cramping and regulates menses due to hormonal balancing properties." (3)
6. Our consultant Mr. Litell reports with appropriate citations to the
scientific literature, that Angelica is used "in the treatment of anemia, skin
conditions and irregular menstruation."
Our consultant Ms. Snow has informed us, with appropriate citations to the
scientific literature, that Angelica "is used in the treatment of anemia, skin
conditions and irregular menstruation."
Celery Seed
1. We found no submission of a Celery Seed claim to FDA. But FDA has declared it
GRAS. (21 C.F.R. 182.10-.20)
2. This ingredient is not part of the German Commission E. monograph series.
3. The Herb Research Foundation has gathered scientific evidence to substantiate
claims for Celery Seed.
4. The American Botanical Council has provided us with an article discussing the
uses of Celery Seed, which cites and discussed sixteen relevant articles from
the scientific literature. The oil has "reportedly [been] used as
diuretic, as a
nervine and
antispasmodic." Widespread use of the seeds in Europe to treat a
variety of illnesses is also noted.
5. Mowrey, The Scientific Validation of Herbal Medicine, reports,
with citations to the scientific literature following each sentence, that Celery
Seed "is a traditional
diuretic and blood cleanser."
6. Mr. Litell reports that Celery Seed is effective as a
diuretic, and for
support of the lungs. Ms. Snow reports that Celery Seed is a "Mild diuretic and
mild spasmolytic."
Chamomile
1. FDA has not objected to the following DSHEA submissions for Chamomile:
"naturally promotes relaxation"; "relaxes digestive tract"; "reinforcement for .
. . stress"; "strengthens digestive functions"; and "helps the body relax and
supports digestion". Chamomile is GRAS. (21 C.F.R. 182.10-.10.)
2. The Commission E monograph finds Chamomile effective for gastrointestinal
spasms.(Monograph 228).
3. The Herb Research Foundation has gathered scientific evidence to substantiate
claims for Chamomile.
4. The American Botanical Council has provided us with a summary article on
Chamomile, which is backed by 32 relevant, supporting scientific articles.
Chamomile has reduced "blood urea concentrations." "It is also used for
gastrointestinal spasms." Other uses include as "mild sleep aids,
antispasmodics, [and] digestive aids".
5. Mowrey, The Scientific Basic of Herbal Medicine, reports that Chamomile
"possesses a definite and proven uterine tonic property [as shown]in one careful
and controlled study. Also well documented are the mild-sedative properties of
Chamomile. One can expect a nice positive interaction between the effects of
Passion Flower and Chamomile . . . [A] tremendous amount of clinical,
therapeutic and experimental work [has] been done on Chamomile. Of the many
therapeutic properties [of Chamomile] substantiated . . . only a few are listed
here: "antispasmotic,
carminative, antimycotic."
The same author's Herbal Tonic Therapy, reports that "Chamomile has relaxing
properties of a tonic nature"; "Chamomile has a mild calming action on the
digestive system"; (186-188).
Jones, Medicinal Herb Handbook, states that Chamomile "helps with
acid indigestion and gas from food fermentation, decreasing the ability of the
nerves to repolarize; may also help in morning sickness and general nausea".
(5)
6. Ms. Snow reports that Chamomile is a "carminative, mild sedative, and
anti-catarrhal. [It is] [u]sed to treat flatulent nervous dyspepsia, travel
sickness, nasal catarrh, nervous diarrhea, and gastrointestinal disturbances",
citing from the scientific literature to support her point.
Dandelion
1. FDA has not taken action against the following claims for Dandelion, which
were submitted to the agency as required by DSHEA, 6: "herb for kidney health";
"herb for liver health"; "supports normal liver function"; "promotes liver
health"; and "used to enhance digestion, and support liver and gallbladder
function . . . assists the liver and gallbladder". FDA has declared that
Dandelion is Generally Recognized as Safe for use in foods. (21 C.F.R. 182.20)
2. The German Commission E monograph found that Dandelion was effective for
disturbances in bile flow, as a
diuretic, for loss of appetite, and for
dyspeptic problems.
3, The Herb Research Foundation has gathered scientific evidence that
substantiates claims for Dandelion.
4. The American Botanical Council has provided an article summarizing the
supported uses of Dandelion, backed up by 14 articles from the scientific
literature. Dandelion root is generally considered to have
diuretic, choleretic,
tonic and laxative properties, among others. The herb is used for appetite and
dyspeptic disorders, such as abdominal fullness and flatulence.
5. Mowrey, The Scientific Basis of Herbal Medicine states that Dandelion root
"acts primarily by purifying the blood, i.e., by straining and filtering toxins
and wastes from the bloodstream . . . Since a healthy liver is required to
provide effective blood detoxification, it is important to note here two studies
that demonstrated a liver-healing property in Dandelion. The first showed that
in human patients, the herb uniformly remedies chronic liver congestion
[citation to study]."
Jones, Medicinal Herb Handbook, states that "this is our best
diuretic because it doesn't deplete potassium, it is good for kidney
inflammations. This 'spring tonic' has blood cleansing effects." (6).
The book, Elements of Health, describes Dandelion as a "bitter herb that
cleanses the bloodstream and liver and increases the production of bile. Used as
a
diuretic, improves function of the pancreas, spleen, stomach, and kidneys."
6. Mr. Litell described its primary uses as being to detoxify the body, and to
treat flatulence.
Ms. Snow explained that Dandelion acts as a tonic and as a
diuretic.
Gentian
1. We have found no instance of Gentian being submitted to FDA in connection
with a structure and function claim under DSHEA. However, Gentian has been
approved by FDA as a food ingredient.
2. Gentian is the subject of a German Commission E monograph, which found this
herb effective for treating digestive disorders, including appetite loss and
flatulence. (Monograph No. 223).
3. The Herb Research Foundation has substantiated the claims made for Gentian.
4. The American Botanical Council provided a summary article, which in turns
cites 19 additional articles from scientific literature, confirming the
effectiveness of Gentian for a variety of claims. "Genetian extracts are used in
tonic preparations." They are also used to stimulate the appetite, improve
digestion, and for the gastrointestinal tract.
5. Mowrey, The Scientific Validation of Herbal Medicine, reports:
"Gentian root is invaluable to the body's circulation and overall health by
bolstering its ability to digest and assimilate food . . . [In two studies]
Gentian root . . . stimulate[ed] the digestive process and eliminat[ed] or
over(came)the cause of digestive problems. In good health or bad, it increases
absorption, assimilation and resorption. The effect of Gentian on the vascular
system is to help insure that the abdominal organs receive a rich supply of
blood. It has also been found that Gentian root increases the sensitivity of
many glands and organs to the effect of adrenalin" (49).
Jones, Medicinal Herb Handbook, reports that Gentian "will
increase assimilation of dietary proteins and fats. It also stimulates appetite
. . ." (7).
Elements of Heath summarizes Gentian's uses: "Stimulates gastric
secretions, aids digestion, stimulates appetite, increases circulation . . ."
Good for liver and spleen function.(52).
6. Mr. Litell concludes that Gentian provides support for the liver, stimulates
bile and acts as a digestive aid.
Ms. Snow explains that Gentian acts as a "digestive stimulant." It is used "as a
tonic, especially in the treatment of anorexia, lack of appetite, and
gastrointestinal atony."
Hops
1. FDA has permitted claims that Hops "naturally promotes relaxation" and
"exerts calming effects, thereby inducing rest."
2. Hops is the subject of a German Commission E monograph, which found this herb
effective for treating sleep disorders and mood problems. (Monograph No. 80)
3. The Herb Research Foundation has scientific material substantiating the
therapeutic claims for Hops.
4. The American Botanical Council provided us with a summary article, which in
turn cites 21 supporting articles from the scientific literature, confirming the
effectiveness of Hops for a variety of indications. These include
antispasmodic
effects on "smooth muscle[s]", "to promote sleep", "for restlessness, other
nervous conditions, and lack of appetite."
5. Mowrey, Herbal Tonic Therapies, points out that Hops are used
"as a mild sedative and sleeping aid", and that these indications have been
"verified . . . [with] good experimental procedures." "Generally, a soothing
relaxing calm is experienced within 20 to 40 minutes after ingesting the herb".
Hops also have "antispasmodic activity", and "help in the treatment of sleep
disorders." (180-182).
Jones, Medicinal Herb Handbook, describes Hops as a "safe sedative
. . . to promote sleep and control nervousness and nervous stomach problems
related to faulty starch digestion and as . . . a mild pain killer." (8)
Elements of Health summarizes the known uses of Hops as "good for nervousness,
restlessness, pain, stress, toothaches, earaches . . . circulation, muscle
cramps." (54)
6. Mr. Litell concludes that Hops have a positive effect on the liver and
lungs.
Ms. Snow reports that Hops have "spasmolytic, aromatic
bitter, and sedative"
effects. It is used to "treat lack of appetite, restlessness, and disorders of
sleep", citing Bradley (ed.), British Herbal Compendium, Vol. I. A Handbook of
Scientific Information on Widely Used Plant Drugs, British Herbal Medicine
Association, Bournemouth, England, 1992.
Horehound
1. FDA has not reported reviewing DSHEA claims for Horehound.
2. Horehound is the subject of German Commission E monographs, which found it
effective as a "digestive aid and appetite stimulant." (Monographs 22, 81).
3. The Herb Research Foundation has scientific evidence substantiating the
claims for Horehound.
4. The American Botanical Council provided a summary Article, supported by
numerous general references and a dozen specific articles from the scientific
literature, confirming the effectiveness of Horehound as a
diuretic and
diaphoretic.
5. Mowrey, The Scientific Basis of Herbal Medicine, concludes that Horehound is
effective to improve respiration "by dilating vessels and acting as a serotonin
antagonist" and "should help alleviate respiratory distress", citing several
specific articles from the scientific literature. " (131, 242).
6. Mr. Litell describes Horehound as "lung specific."
Horsetail
1. FDA has not objected to claims that Horsetail "supports hair, skin,
connective tissue and nails", due to its silica content.
2. Horsetail is the subject of a German Commission E monograph finding it
effective for edema. (No. 84).
3. The Herb Research Foundation has gathered scientific articles and other
evidence supporting the effectiveness of Horsetail.
4. The American Botanical Council provided a summary article, which cites a
number of books and thirteen scientific articles, confirming the effectiveness
of Horsetail for various indications and usages. These include: "Horsetail is
considered mildly
diuretic, hemostyptic, and vulnary." It is used for
"post-traumatic and static edema"; "to promote renal function"; for "digestive
elimination"; as "an adjuvant in weight loss".
Elements of Health summarizes the use of Horsetail: "Used as a
diuretic.
Strengthens hair, nails, bone, and teeth, promotes healthy skin, and increases
calcium absorption.
5. Mr. Litell notes its use for the "bones, connective tissue, skin, hair, nails
and teeth."
Licorice
1. FDA has permitted claims that Licorice provides "soothing benefits for the
stomach, digestive tract, and as an
antioxidant"; "botanical support for
gastrointestinal, liver and respiratory function"; a "digestive herb [which]
benefits and soothes the stomach"; and "scientific research indicates its
soothing benefits for the stomach, digestive tract, and as an antioxidant."
2. Licorice is the subject of two German Commission E therapeutic monographs,
which find it effective for conditions "of the upper respiratory tract."
(Monographs 90,98).
3. The Herb Research Foundation has gathered scientific articles which
substantiate the claims made for Licorice.
4. The American Botanical Council provided a summary article, supported by
numerous books and almost four dozen scientific articles, confirming the
effectiveness of Licorice for a variety of conditions. The article explains:
"Licorice is known to exhibit many pharmacological activities. Its traditional
uses include sore throat, abdominal pain, among others."
5. Mowrey, The Scientific Validation of Herbal Medicine,
repeatedly discussed Licorice as effective for "respiratory ailments, skin
(conditions), [as a] female tonic, blood purification and detoxification,
circulation, fatigue, weight loss, environmental [related conditions], thyroid,
whole body . . . mental alertness".(4).
Jones, Medicinal Herb Handbook, describes Licorice as having "a
soothing influence upon gastric mucosa, an excellent remedy for peptic and
duodenal ulcerations. Used for adrenal exhaustion as a strengthener to that
organ's system" (9).
Elements of Health describes Licorice; "Cleanses the colon, promotes adrenal
glad function, decreases . . . spasms, and increases fluidity of mucus from the
lungs and bronchial tubes. Studies show Licorice root stimulates the production
of interferon." (55).
Passion Flower
1. FDA has not objected to the following claims for Passion Flower: "naturally
promotes relaxation"; "supports natural relaxation"; and "used for relaxation
and rest."
2. The German Commission E therapeutic monograph concluded that Passion Flower
is effective "for the treatment of nervous anxiety" and restlessness. (Monograph
123)
3. The Herb Research Foundation has gathered scientific evidence that
substantiates claims for Passion Flower.
4. The American Botanical Council has provided an article summarizing the
supported uses of Passion Flower, backed by 26 articles from the scientific
literature and a number of books. Those uses include "analgesic and sedative
properties", "tranquilizing effects", "antispasmodic,
anxiolytic, and
hypotensive activity reported", "employed as antispasmodics for digestive
spasms."
5. Mowrey, The Scientific Validation of Herbal Medicine, notes
that Passion Flower "is used primarily as a sedative . . . [and] to calm nerves
that get on edge during the periods of hormonal adjustment common to most
women." Another use is "to relieve pain [an] effect [that] has been demonstrated
in laboratory and clinical tests", citing the studies. Passion Flower "is often
used to induce relaxation and sleep, an effect first experimentally verified in
1920", again citing articles. (109, 165).
Jones, Medicinal Herb Handbook, describes Passion Flower as
follows: "The anti-spasmodic, sedative and mood elevation qualities have value."
(10)
6. Mr. Litell states that Passion Flower is used for nervous conditions, and for
relaxation.
Ms. Snow describes Passion Flower as "antispasmodic, sedative [and]
anxiolytic",
"is [u]sed in nervous stress, restlessness, sleep disorders, anxiety, and
neuralgia."
Peppermint.
1. FDA has not objected to claims that Peppermint is "soothing . . . for head
and digestion" and has a "soothing effect on the stomach."
2. Peppermint is the subject of two German Commission E therapeutic monographs,
which find it effective "for spastic complaints of the gastrointestinal tracts
as well as [the] gallbladder and bile ducts . . ."(Monographs 124, 125)
3. The Herb Research Foundation has obtained scientific articles that
substantiate claims for Peppermint. The Foundation has also published a
monograph on Peppermint by the noted herbalist, Steven Foster. Mr. Foster's
monograph points out that "scientific studies have confirmed a rational basis
for traditional uses of the plant, while suggesting further safe and effective
use of Peppermint oil products as a direct or adjunct therapy in modern
practice."
4. The American Botanical Council provided a summary article, with citations to
52 scientific articles and many books, supporting the effectiveness of
Peppermint for various indications. These uses include "carminative, antiseptic,
and local anesthetic" and for "indigestion, nausea, sore throat, diarrhea,
headaches, toothaches, and cramps."
5. Mr.Litell noted that Peppermint Oil aids the liver and assists circulation at
the capillary level.
Ms. Snow reports that Peppermint Oil is "used for dyspepsia, flatulence", citing
the British Herbal Compendium, among other literature.
Sarsaparilla Root
1. There apparently are no instances where companies submitted to FDA a DSHEA
claim for Sarsaparilla root.
2. Sarsaparilla root is not covered by the German Commission E monograph
program.
3. The Herb Research Foundation has not yet collected data on the safe and
effective use of Sarsaparilla.
4. The American Botanical Council provided a summary article, supported by eight
citations from the scientific literature, confirming the effective use of
Sarsaparilla. These uses have been "reported to facilitate the absorption by the
body of other drugs"; and "reported to have hepatoprotective and
diuretic
activity. Sarsaparilla is "used in certain tonics" and is "[u]sed generally as a
tonic."
5. Mowrey, The Scientific Validation of Herbal Medicine, reports
that Sarsaparilla was independently discovered to be "a good candidate for a
whole body tonic." (3). He further points out that "Sarsaparilla root actually
attacks microbial substances in the blood stream, neutralizing them". "The plant
is also a strong
diuretic . . . stimulating the excretion of wastes such as uric
acid and excess chloride." It "is also a diaphoretic - - by promoting sweating,
still more toxins are removed from the lymph and circulatory systems."(19).
Mowrey, Herbal Tonic Therapies, confirms the fact that
Sarsaparilla "has enjoyed a long reputation as a blood purifier and tonic [and
is] an herb that facilitates the removal of wastes from the blood, either by
promoting better circulation, or improving liver and kidney action." (293)
Jones, Medicinal Health Handbook reinforces the impact of Sarsaparilla on the
blood system: "For anemia and low hemocrit, this plant is called a 'coadaptogen'
and will basically return an overactive or sluggish system to normalcy . . . it
acts to repair liver and kidney deficiency; has mild laxative effects and is a
growth stimulant; works well with Licorice . . ." (12).
Elements of Health confirms it is "used for the liver, stress and other
disorders caused by blood impurities . . ." (58).
6. Mr. Litell describes Sarsaparilla root as "a blood cleanser and liver tonic."
Saw Palmetto
1. FDA has not objected when informed that companies intended to make claims on
their labels that Saw Palmetto "maintains prostate health and well being";
supports "healthy prostate function"; 'use specifically for men's health";
"helps maintain proper urinary function"; "the leading herb for men's health";
"supports the health and function of the urinary tract and the prostate gland";
Saw Palmetto can help the body maintain healthy hormone levels"; and literally
dozens of other, comparable claims.
2. The Herb Research Foundation has gathered scientific literature
substantiating the claims for Saw Palmetto.
3. The American Botanical Council provided a summary, supported by 23 scientific
articles, demonstrating that Saw Palmetto is "considered to have
diuretic,
sedative, antiandrogenic, antiexudative, and [other] effects." "A number of
double-blind, placebo controlled clinical studies published in recent years
(involving over 600 patients) suggests that [Saw Palmetto] extracts improve
objective and subjective symptoms, including dysuria, nocturia, and frequent and
poor urinary flow." in citing seven separate articles. It is "traditionally
considered [an]
expectorant, sedative and
diuretic."
4. Mowrey, The Scientific Validation of Herbal Medicine, concludes
that Saw Palmetto "although specific for certain diseases of the prostate and
reproductive organs, is generally effectively used for nutritional support of
all bodily systems" (68). He notes that "doctors . . . have prescribed it to
stimulate the appetite, improve digestion and increase assimilation" (77). "It
functions as a nutritive tonic."
Thyme
1. It appears that there have been no DSHEA submissions to FDA for Thyme.
2. Thyme is the subject of two German Commission E therapeutic monographs, which
find it effective "for symptoms of congestion of the upper respiratory tract:"
(Monographs 170, 228).
3. The herb Research Foundation has gathered scientific articles substantiating
the claims for Thyme.
4. The American Botanical Council provided a summary article, citing numerous
books and 22 scientific articles, substantiating the claims for Thyme. These
include "antispasmodic,
expectorant, and
carminative."
Minerals
This tonic also contains numerous minerals, including potassium, calcium,
magnesium, and boron. All are required nutrients. We summarize below the various
claims, made under DSHEA for the health effects of these nutrients, to which FDA
has lodged no objection.
A. Potassium: "ensures proper physiological functioning of diverse organ
systems" (1/2/96); "involved in the regulation of cellular water balance"
(12/15/97); "maintains healthy muscles, nerves and heart" (11/2/98); and
"important in tissue fluid regulation, nerve impulses, muscle contractions,
cellular metabolism and enzyme reactions" (10/30/98).
B. Calcium: "helps to maintain a regular heartbeat" (6/11/96); "helps maintain
healthy cardiovascular function" (10/19/98).
C. Magnesium: "aids your central nervous system" (1/8/98); "helps nerves and
muscles function" (10/26/98); "essential in converting blood sugar into energy"
(9/11/98); supports "healthy function of the muscles, cardiac and nervous
systems . . . aids in the absorption and metabolism of other vitamins"
(10/30/98); and "required for over 300 metabolic reactions in the body . . .
essential for cardiac rhythm of the heart and blood pressure . . .supports the
function of the cardiac muscle . . . shown to support arterial wall tone"
(12/16/98).
D. Boron: "aid in reducing calcium loss" (10/31/97).
This
comprehensive memorandum clearly supports the mild and limited claims made for
Jurak Classic Whole Body tonic - - even though we barely scratched the surface
of the available scientific literature on the Tonic's ingredients. For example,
we did not discuss the dozens of supporting books, and over 200 scientific
articles, listed in the American Botanical Council materials. We did not track
the German Commission E monograph in any detail. Nor did we use any of the
authoritative, classic herbal texts available, such as the British Herbal
Compendium.
However, there is one definitive guide consulted by every physician and health
car professional who uses or prescribes herbs for their benefits to good health:
The Physicians Desk Reference to Herbal Medicines (Grunewald, ed., 1998). This
is the companion volume to the PDR, the essential guide to prescribing drugs.
The PDFR for Herbal Medicines defines which herbs are effective for various
medical conditions, thus guiding physicians in their use. It has found effective
almost every ingredient in the Jurak Classic Whole Body tonic, as follows:
° Alfalfa: Acts "on the cardiovascular, nervous, and digestive systems";
° Celery Seed: "used as a
diuretic, for blood purification, for regulating
elimination of the bowels, for glandular stimulation, pneumatic complaints.
Celery Seed is also used for weight loss due to malnutrition, for loss of
appetite, exhaustion, and as a prophylactic for nerves . . .";
° Chamomile: "[H]as antiphlogistic and
antispasmodic, effects";
° Dandelion: "Dandelion is used for disturbances in bile flow, stimulation of
diurisis, loss of appetite, and dyspepsia";
° Gentian: "Used for digestive disorders, such as loss of appetite, fullness,
and flatulence [and] dyspepsic complaints";
° Hops: A "sedative and therefore sleep inducing [use for] nervousness...
"Useful as a sleeping aid and for restlessness and anxiety . . . to stimulate
the appetite and increase the secretion of gastric juices";
° Horehound: Indications; "dyspeptic complaints, liver and gallbladder
complaints, loss of appetite." "[U]sed for dyspepsia, loss of appetite, bloating
and flatulence, and respiratory catarrh";
° Horsetail: Indications: "stimulates urinary tract, kidney". [U]sed for
post-traumatic and static edema";
° Licorice: "According to clinical studies, (it) may (also) be an
expectorant
and antiphologestic";
° Mallow: "A mucus membrane protective effect; relieves irritation because of
the high level of muculagous material." "Used for irritations of the oral and
pharyngeal mucosa, dry irritated coughs";
° Malva Flowers: Used for the respiratory tract and the gastrointestinal
tract";
° Passion Flower: "Passion Flower is used for nervous agitation, mild insomnia,
and nervous gastrointestinal complaints";
° Peppermint: "[U]sed internally for cramps of the upper gastrointestinal tract
and bile ducts, irritated colon, catarrh of the respiratory tract and loss of
appetite";
° Sarsaparilla Root: "Used as a
diuretic and dysphonic";
° Saw Palmetto: "[It] relieves only the difficulties associated with an enlarged
prostate without reducing the enlargement".
° Thyme: "Thyme is a bronchial
antispasmodic, an expectorant";
Thus, it is more than well established that the ingredients in Jurak Classic
Whole Body Tonic have a variety of health promoting properties. In the
scientific literature, many of these ingredients are identified as appropriate
for use in a whole body tonic. For example, Sarsaparilla is referred to
specifically as a "good candidate for a whole body tonic" (see discussion
above.) Here, they have been combined to balance and optimize their effects, and
provide a source of help to those individuals who are concerned about their
health. (Moreover, as noted above, we make reference here to only a tiny
fraction of the materials, textbooks, and scientific literature confirming the
effects of the ingredients in Jurak Classic Whole Body Tonic.)
Moreover, Congress has set up specific procedures, and a particular Federal
agency, to review all Dietary Supplement products and claims. The procedures,
established in the Dietary Supplement Health and Education Act of 1994, require
that whenever a manufacturer of any dietary supplement - - tablet, liquid, pill,
capsule, etc. - - wishes to market his product, he must provide to the FDA, its
name, and include the claim or claims that will be made (or are being made) for
that product. (21 C.F.R. 101.93)
FDA reviews the claims for the product. If it feels the claims violate the law,
usually because drug claims are made on the label, its practice since 1995 has
been to send the company either a "warning letter" or an "untitled letter",
explaining the violations, and asking that the claims be halted. If FDA feels
the claims are not objectionable, it does not respond to the company. Thus, the
failure to receive an FDA letter mans, as a practical matter, that FDA does not
object to the product and its claims. In the case of Jurak Classic Whole Body
Tonic, the submission was made, and FDA raised no objection either to the
product, or the claims.
1.
Explain what "health giving substances" a tonic gives to the body.
The herbal and mineral ingredients in Jurak Classic Whole Body Tonic provide
a variety of "health giving substances" to those consumers who use this product.
For example, Angelica (Dong Quai) "helps maintain a woman's health and
well-being during and after menopause"; this is obviously a health benefit, and
one that FDA has not objected to on other products. Other health giving
substances in this Tonic, which have not been objected to by FDA, include
Chamomile ("strengthens digestive functions", "helps the body relax"); Dandelion
("used to enhance digestion and support liver and gallbladder function"); Hops
("exerts calming effects, thereby inducing rest"); Horsetail ("benefits hair,
skin, connective tissue, and nails"): Licorice ("support for gastrointestinal,
liver and respiratory function"); Passion Flower ("used for relaxation and
rest"); Peppermint ("soothing effects on the stomach" and "digestion"); and Saw
Palmetto ("support the health and function of the urinary tract and the prostate
gland").
Likewise, the Whole Body Tonic contains a number of minerals, which are clearly
health giving substances: The FDA has established RDI's and necessary Daily
Values for them. Moreover, FDA has reviewed, and not objected to, every one of
the following claims for the minerals in Whole Body Tonic: Potassium ("ensure
proper physiological functioning of diverse organ systems", maintains healthy
muscles, nerves and heart"); Calcium ("helps to maintain a regular heartbeat",
"helps maintain healthy cardiovascular function"); and Magnesium ("essential in
converting blood sugar into energy", "required for over 300 metabolic reactions
in the body", "essential for cardiac rhythm of the heart, and blood pressure").
For one function or another, each herb and mineral in the tonic formula is a
"health giving substance".
2.
What do you mean by your statements that these substances balance, purify and
activate the blood . . . and create conditions which bring well being.
This question rises two separate issues: which ingredients in Whole Body
Tonic have a purifying or other effect on the blood, and which ingredients
instill a sense of well being. We will answer them separately.
First, there are those ingredients which have a direct impact upon the blood, as
well as those which have an impact by influencing the liver or related organs.
In this formula, four ingredients with the known capacity to cleanse the blood
have been included. Dandelion is an ingredient which "acts primarily by
purifying the blood", and has "blood cleansing effects". Celery Seed is a blood
cleanser. Gentian activates the blood because it increases circulation. Angelica
also increases circulation by dilating blood vessels.
Supporting the effect of these blood cleansing agents are ingredients
which aid liver function. These are Sarsaparilla, which "repairs liver
deficiency", and Alfalfa, which is a general agent of detoxification. FDA has
not taken action on submitted claims of this sort for these ingredients.
Second, a number of herbals are included because they "create conditions
which bring well being." Most of these are relaxants, ingredients which fight
stress or bring on relaxation. These include Chamomile, for which FDA has not
objected to claims that his herb "naturally promotes relaxation", and
"reinforcement for . . . stress"; Hops ("naturally promotes relaxation", and
"exerts calming effects, thereby inducing rest"); Passion Flower ("supports
natural relaxation", "used for relaxation and rest"); and Celery Seed.
Every Tonic is a blend of herbs and minerals, with individual ingredients
intended to work with others to provide benefits to each organ system.
3.
You have stated that "many" people have used these products for years. Quantify
what you mean by "many". If you are unable to support this statement, delete
it.
A claim that "many" people have used a product, including using a dietary
supplement, is the sort of natural "puffery" which does not require hard and
fast numerical support. We are unaware of any case where the FTC charged that
any claim for use by "many" consumers was "false or misleading" (the FTC
standard) because it could not be backed by a precise number of individuals
purchasing a product for any particular length of time.
Nevertheless, Jurak Tonic was sold world-wide beginning in 1946, and its sales
continued for years. Hundreds of thousands of units were sold during this period
of time, and there were numerous repeat sales. The product was, in short, highly
successful in the marketplace.
By any definition of the term, the, there were obviously "many" individuals who
consumed this product for years. Indeed, the product came back to market several
decades later.
6.
In the second full paragraph on page 12, discuss the primary ingredients of your
products and the effects of these ingredients.
We make no reference to a "primary" ingredient or "primary ingredients" in
the tonic, probably because it is no more possible (and no more profitable) for
an herbalist to select the primary ingredient among his herbs, than it is for
the father of a large family to select his "primary" child.
If "primary" is defined as those ingredients which have either the most
substantial impact on health, or the most substantial body of supporting
literature (including FDA's acceptance of their structure and function claims),
then the herbs that are "most primary" are Chamomile, Dandelion, Licorice,
Passion Flower, Peppermint, and, probably first among equals, Saw Palmetto. But
every ingredient, including the minerals, has a significant role to play in the
tonic, and thus could be thought of (for one bodily organ, system or problem) as
a "primary" ingredient. None of the ingredients in Jurak Classic Whole Body
Tonic is simply "along for the ride."
Sincerely,
REGULATORY STRATEGIES CONSULTANTS
By: William D. Appler, M.A.
