U.S. FOOD AND DRUG ADMINISTRATION
Regulations on Statements Made )
for Dietary Supplements Concerning ) Docket No. 98N-0044
the Effect of the Product on the )
Structure or Function of the Body)
DURK PEARSON & SANDY SHAW
PEOPLE FOR THE CONSTITUTION
Durk Pearson & Sandy Shaw ("Pearson & Shaw") and People for the Constitution ("People") hereby submit their joint comments in response to the call for public comments on the above referenced matter published in the April 29, 1998 Federal Register (Vol. 63 No. 82, pp. 23624-23632.
Durk Pearson & Sandy Shaw are research scientists and authors, specializing in the study of aging, age-related diseases, and free-radical associated disorders. They have spent thirty years studying the biochemistry of aging processes, nutrient-disease relationships, and FDA policies. In 1990, they received the Paul F. Glenn award of the American Aging Association, a professional society, for their educational activities directed to the public via books, articles, radio, and television concerning aging research and its practical implications. They have published four books, including three bestsellers. One, Life Extension, a Practical Scientific Approach (Warner Books, 1982), was on the New York Times Bestseller List for ten months and was #1 on the list for several weeks. They have also published a book on FDA regulatory policies concerning health claims, Freedom of Informed Choice: FDA v. Nutrient Supplements (Common Sense Press, 1993), which discusses the First Amendment implications of FDA's regulations. Pearson & Shaw have created several popular and safely used lines of dietary supplements, which they take themselves, that are marketed worldwide by license. Pearson & Shaw wish to communicate more truthful, nonmisleading scientific information about the health effects of their dietary supplements to consumers who wish to receive such information.
Pearson & Shaw are also plaintiffs in Pearson & Shaw et al v. Food & Drug Administration et al, No. 98-5043, which has been consolidated with case No. 98-5084 and is currently before the United States Court of Appeals for the District of Columbia Circuit. This case challenges certain FDA regulations concerning health claims as a prior restraint and violation of the plaintiffs' First Amendment protected speech rights. The briefs and filings in this case may be downloaded from www.emord.com.
People for the Constitution ("People") is a public interest organization that informs the public about their constitutional rights and the limits the Constitution places upon Federal government regulatory powers, including the regulation of communication of truthful, nonmisleading scientific information. People also commissions legal research on Constitutional issues in preparation for possible litigation against the Federal government in defense of Constitutional rights, including those of the First Amendment.
Members of People wish to communicate more truthful, nonmisleading scientific health information about dietary supplements and to receive such information.
The FDA's proposed new rules for allowable structure/function claims:
1. Violate the First Amendment by placing a prior restraint on truthful, nonmisleading scientific information about dietary supplements, including that from published peer reviewed scientific papers.
2. Reduce the amount of information that may be communicated on labels and in labeling of dietary supplements, in opposition to the express will of Congress as explained in Public Law 103-417 (DSHEA) that "there is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health," "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," and that "...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."
3. Are "arbitrary and capricious and not according to law" under the APA because the FDA's proposed definition of "disease" is so encompassing that nearly all truthful nonmisleading structure/function information about a dietary supplement would provide information directly or indirectly relating to the treatment, cure, diagnosis, or risk reduction of a "disease" and, therefore, be disallowed.
In Section I. Introduction, FDA states "FDA also notes that a dietary supplement for which only structure/function claims are made in the label or labeling in accord with section 403(r) of the act [DSHEA] may nevertheless be subject to regulation as a drug if the agency has other evidence (see 21 CFR201.128) that the intended use of the product is for the diagnosis, cure, mitigation, treatment, or prevention of disease."
COMMENT: There is nothing in the DSHEA authorizing the FDA to treat dietary supplements as drugs when there is no disease claim made for the dietary supplement. In Sec. 3 (DSHEA), it states that "Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act." Moreover, the use of a supplement is not determined by the manufacturer or vendor of a supplement, but by consumers, in which the limit of each individual consumer's knowledge plays a key role.
COMMENT: FDA's proposed rules defining "disease" and acceptable structure/function claims are arbitrary and capricious and are so complex, contradictory, and overlapping that it is impossible to determine just what truthful speech is left that may be communicated after all possible disease references, allusions, inferences, and implications have been ruled out and is, therefore, unconstitutional, being void for vagueness. For example:
IIB(4) "Under proposed 101.93(g)(1), a 'disease' is any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by a characteristic set of one or more signs or symptoms."
IIC "FDA emphasizes that in determining whether a statement about a product constituted a disease claim under these criteria, FDA would also consider the context in which the statement appeared. A statement that by itself would be considered an acceptable structure/function claim could become a disease claim if, in context, an effect on disease were expressed or implied."
IIC(2): "FDA believes that reference to a characteristic set of signs or symptoms, even in the absence of the name of the disease, can be understood as a reference to the disease itself." "Claims of an effect on symptoms that are not recognizable as characteristic of a specific disease or diseases would not constitute disease claims."
COMMENT: Health is not just the absence of disease, but the absence of disease is certainly a significant and necessary part of health. The only sort of structure/function information that escapes the labryinth of FDA's all-encompassing rules and regulations on disallowed information is information that is so vague that it is very unlikely to help consumers make informed choices for preventive health care. For example, the FDA will allow (it says) a claim that a product "helps maintain a healthy cholesterol level," but would not allow a claim that a product may help reduce cholesterol levels (even if true) because the latter would be a "disease" claim. What, then, does the FDA's acceptable claim mean when it says that the product "helps maintain a healthy cholesterol level?" If the product does help maintain a healthy cholesterol level, it must mean that it lowers cholesterol, at least under some circumstances, to help maintain a healthy cholesterol level. If the product cannot help lower cholesterol levels or (to put it another way) cannot help prevent cholesterol levels from rising, how can it help maintain healthy cholesterol levels? We believe that the FDA approved statement "helps maintain a healthy cholesterol level" is likely to be interpreted by consumers as meaning that it helps lower cholesterol levels. Indeed, niacin and some antioxidant vitamins (including vitamins E and C in certain dose ranges) do appear to help lower LDL cholesterol levels in many people and this is important information for consumers to know, but under FDA's proposed rules is prohibited by a prior restraint.
The FDA says that a claim that a product "helps maintain cardiovascular function and a healthy circulatory system" is OK, but to say that the product "may reduce cholesterol levels" is not OK. The latter contains helpful information for the many consumers who are trying to "maintain cardiovascular function and a healthy circulatory system" by reducing their cholesterol levels, but the vague claim that a product helps "maintain cardiovascular function and a healthy circulatory system" does not tell the consumer anything about what the product actually does (or purports to do). Information about a product's mode of action (its mechanism) is key information as to whether a product is likely to do any particular person any good. When significant scientific evidence supports a particular mechanism of action of a dietary supplement, that information ought to be permitted (indeed, it should be encouraged) to be made available to the public.
FDA does allow that "Claims of an effect on symptoms that are not recognizable as characteristic of a specific disease or diseases would not constitute disease claims." They then state that examples of such claims would be "reduces stress and frustration," "inhibits platelet aggregation," and "improves absentmindedness." Doesn't the first claim suggest that the product could be used as a tranquilizer? A product that "inhibits platelet aggregation" is very likely to reduce the risk of a heart attack or occlusive stroke for many people since platelet aggregation is one of the ongoing processes in most heart attacks and occlusive strokes. It is apparently only because most members of the general public are unaware of this that the FDA considers this claim to be acceptable. Once the general public becomes aware of the disease implications of platelet aggregation, then, presumably, this claim too will become unacceptable since it will clearly be a "disease" claim. Moreover, "absentmindedness" is universally recognized as characteristic of age-related memory loss or even Alzheimer's disease. Why is "improves absentmindedness" allowed but "lowers cholesterol" prohibited? Under the proposed rule, it is impossible for the regulated to determine what is legal and what is illegal. The proposed regulations are arbitrary, capricious, in violation of the express will of Congress, and void for vagueness.
Another example of the inconsistency of the FDA's distinction between allowed and non-allowed structure/function claims: FDA will permit "supports the immune system," but will not permit "supports the body's ability to resist infection." But, since it is the immune system itself that fights infection, supporting the immune system may very possibly support the body's ability to resist infection. Again, though, "supports the immune system" is less useful to consumers because it provides less specific information; it does not explain what particular aspect of immune activity is supposedly supported, eg., the mechanism of the supplement's effects (or purported effects). Again, the FDA doesn't want too much information to be provided, lest the consumer might make the connection between a truthful description of the effect of a dietary supplement and a disease, and purchase the supplement for the prevention or amelioration of that disease. As the U.S. Supreme Court noted in 44 Liquormart, "a State's paternalistic assumption that the public will use truthful, nonmisleading commercial information unwisely cannot justify a decision to suppress it." "It is precisely this kind of choice, between the dangers of suppressing information, and the dangers of its misuse if it is freely available, that the First Amendment makes for us."
We note that the FDA's attempts to severely narrow the limits of acceptable scientific information (structure/function claims) that may relate to the treatment, cure, or prevention of disease will hurt most those who are the least knowledgeable. Some of the well educated and well read are already likely to know about platelet aggregation and its implications for heart attacks and occlusive strokes, for example, whereas the poorly educated are not. About the time the poorly educated start to become aware of the link between platelet aggregation and heart attacks and occlusive strokes, the FDA will (under the new rules proposed here) proclaim this information to be an unacceptable disease claim, thus preventing the poorly educated from benefiting from this information in making dietary supplement choices. Hence, the FDA's policy of restricting the flow of truthful information has a disparate impact on the poor and less well educated.
The FDA says, in IIC(4)(c): "Citation of a title of a publication or other reference, if the title refers to a disease use" would render a product to have a "disease" claim even when otherwise no disease claim is made.
COMMENT: The DSHEA (Sec. 403B) expanded the permissible communication of scientific information on dietary supplement labels and in labeling: "A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it is not false or misleading" and meets certain other conditions. Now the FDA attempts to restrict the communication of scientific information made expressly permissible under the DSHEA by banning the citation of scientific papers in which the title contains a reference to a disease use. The DSHEA section on use of citations does not authorize this proposed FDA requirement and it severely strains the imagination that Congress authorized the use of certain published abstracts of scientific papers without intending that the title of the papers be used, as well.
Moreover, Section 403B(c) of this section of DSHEA notes that "Burden of Proof: In any proceeding brought under subsection (a), the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading." FDA proposes a blanket ban on the citation of scientific papers in which the name of a disease appears in the title, but has provided no evidence that all (or even any) such scientific papers would be false or misleading.
We recommend that the FDA reviewers of these comments download the Appellants' Reply Brief (www.emord.com) in Pearson & Shaw et al v. Food and Drug Administration et al (Case No. 98-5043 and Consolidated Case 98-5084) for, among other things, extensive citation of Senate, House, and other Congressional reports on the failure of the FDA to meet the Congressional intent in NLEA and DSHEA to increase the communication of truthful, nonmisleading information to the public on dietary supplements. For example, the FDA was not to require "definitive proof" of a nutrient-disease relationship before authorizing claims, but was to depend upon evidence that a "significant segment of scientists having relevant expertise agree...that consumers are reasonably likely to obtain the claimed health benefit." S.Rep. 103-410 at 34. Also, "The FDA has acted to restrict the information that the public may receive about dietary supplements." S.Rep.103-410 at 16. And again, "FDA has applied [significant scientific agreement] in a way that limits consumer access to important information on diet and health." S.Rep. 103-410 at 23. And again "Despite the fact that the scientific literature increasingly reveals the potential health benefits of dietary supplements, the Food and Drug Administration has pursued a regulatory agenda which discourages their use by citizens seeking to improve their health through dietary supplements." S.Rep. 103-410 at 14.
The FDA's attempt to ban communication of certain truthful and nonmisleading scientific papers when the title has the name of or refers to a disease is in violation of the First Amendment. Scientific speech is fully protected. We note here for the record that we will not be limited by this unconstitutional rule and will cite any and all scientific papers we think relevant, whatever their title may be. If the FDA makes an issue of this, then we will cite these papers with the name of the disease removed and replaced with a bracket: "[word or words removed because of FDA threats, in violation of our First Amendment rights. Sieg heil!]". We do not think that consumers, the scientific community, the Congress, health freedom activists, or the courts will be amused by the FDA's blatantly unconstitutional censorship and blatant violation of the clear written intent of Congress in the official records to increase the flow of health information to the public.
We intend to propose that Congress hold "contempt of Congress" hearings on the FDA's continuing resistance to the clear instructions of the Congress in the NLEA and DSHEA to increase the amount of information flow on the health effects of dietary supplements to consumers. We believe that until there are actual punishments in place for specific FDA rulemaking individuals responsible for wilfully refusing to comply with the statutory instructions of the Congress, we will see this sort of unlawful behavior taking place again and again. (For example, who at FDA is responsible for writing these proposed new rules?) The FDA seems to forget that Congress has the sole Constitutional authority to make Federal law and that the FDA's authority to implement laws passed by the Congress comes from the Congress and may be taken away and given to another agency by the Congress, and agency rulemakers found to be in contempt of Congress may be imprisoned.
Comments submitted by:
Durk Pearson & Sandy Shaw
People for the Constitution
PO Box 3666
Tonopah, NV 89049
Dated: Sept. 23, 1998
© Copyright 1999 by Durk Pearson & Sandy Shaw
NOTICE: The "Durk Pearson & Sandy Shaw Life Extension News" is for informational purposes only. Its contents are not intended as advice for the diagnosis, treatment, or cure of any medical condition. Pearson & Shaw are scientists, not doctors. If you have a medical condition, see a physician. Durk Pearson & Sandy Shaw® do not own any part of any dietary supplement company. They license their formulations and receive royalties on sales. The formulations they design and use are those which contain their names on the label.