Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -429

Accepted - Volume 6

Comment Record
Commentor Mr. Michael McGuffin Date/Time 2002-09-15 18:47:00
Organization American Herbal Products Association
Category Association

Comments for FDA General
Questions
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? AHPA and its members are concerned about the regulation of commercial speech about dietary supplements and over-the-counter drug products containing botanicals that are marketed based on their status as not new drugs. It is AHPA's position that any administrative record for regulating commercial speech regarding these products must meet the standards set out by the Supreme Court in Thompson v. Western States Medical Center, 122 S. Ct. 1497 (2002). It is AHPA's position that FDA would have to have a substantial administrative record to support the position that certain promotional speech is inherently misleading unless it first complies with some FDA requirement. And it is AHPA's position that the nature of the audience for commercial speech (learned intermediaries or consumers) is an important factor to be considered with respect to the nature of the administrative record necessary to support a commercial speech regulation. Many botanicals are taken by consumers, or recommended or dispensed by health care practitioners (not necessarily medical doctors but often naturopaths or chiropractors) to consumers for conditions that are defined as diseases under FDA regulations. 21 C.F.R. 101.93(g). FDA regulations prohibit dietary supplements from making disease claims in labels or labeling. It is AHPA's position that it is nonetheless lawful under the Federal Food, Drug, and Cosmetic Act to advertise such products for use in the treatment of diseases so long as such advertising is not false or misleading or does not constitute a deceptive act or practice under the Federal Trade Commission Act. An example of such products would be those that are demonstrated to be effective in lowering cholesterol. FDA has made clear that only limited label or labeling claims may be made about cholesterol-affecting dietary supplements, e.g., helps support healthy cholesterol levels in persons with normal cholesterol levels. There are, however, a number of dietary ingredients that have been demonstrated in adequate and well-controlled clinical trials to lower cholesterol, even though those ingredients have not been submitted for new drug approval. Utilization of such data to make claims in advertising for dietary supplements should not cause FDA to take regulatory action under theories either that the advertising falls under some broad interpretation of the definition of labeling or that it evidences an intent by the company making the claim to market its product as a drug. It is AHPA's position that the free flow of this commercial information should not be deemed by FDA to be prohibited by dietary supplement or drug regulations. AHPA believes that there should be greater deference paid by FDA as a regulator where commercial information is communicated to learned intermediaries than to consumers. The efficacy of botanicals for treatment of diseases is supported by historical (or traditional) literature and by adoption for monograph uses by certain foreign government bodies. Truthful and not misleading communications about the conclusions regarding botanicals in either literature or government monographs to learned intermediaries, including the full citation and even copies of such materials or monographs, should be viewed by FDA through the prism of the learned intermediary as opposed to the prism of ordinary consumers, people which, in the words of Mr. Justice Frankfurter (United States v. Dotterweich, 230 U.S. 277 (1943), in the circumstances of modern industrialism, are largely beyond self-protection.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? It is AHPA's position that it is lawful to make structure function claims for foods based on the effect on the structure or function of the body of the food or the ingredients contained therein. With respect both to food and dietary supplements, under FDA nutrient content claims regulations (21 C.F.R. 101.13 and 101.65), food and dietary supplement products may not make Contains claims on labels or in labeling unless that claim is for one of the nutrients designated in the Federal Food, Drug, and Cosmetic Act or in an FDA regulation. The statute goes too far in regulating the communication of truthful and non-misleading Contains information to consumers. The statute and the regulations assume that whenever consumers are advised that a product Contains an ingredient that they will be (mis)led to the conclusion that the ingredient is a statutorily defined nutrient. Thus, the truthful claim Contains echinacea is not allowed on the label of a botanical dietary supplement that in no way purports to provide nutrient value to the consumer. Moreover, the Supplement Facts panel on information panel of such a product would state clearly that there are no nutrients in the product. Accordingly, the statute and the regulation are, AHPA believes, impermissible restrictions on truthful and not misleading commercial speech.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? It is AHPA's position that the Dietary Supplement Health and Education Act of 1994 granted FDA regulatory authority over labels and labeling of dietary supplements. That law did not extend that regulatory authority to advertising which has been regulated under the Federal Trade Commission Act for over fifty years. The Supreme Court has now set forth clear standards under which FDA may regulate commercial speech. The Federal Trade Commission is controlled by the same Supreme Court decision but most action by the Federal Trade Commission is taken after the Commission or its staff has reason to believe that there is false or misleading advertising or unfair or deceptive acts or practices. It is AHPA's position that the Federal Trade Commission practice of bringing cases against those alleged to be engaged in false or misleading advertising or other unfair or deceptive acts or practices is a better route under the First Amendment as it has been interpreted to apply to commercial speech than the usual FDA route of trying in advance to circumscribe commercial speech by regulation.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? Setting aside for a moment the Supreme Court's recent decision, FDA's practice of trying to circumscribe, regulate or guide commercial practices in advance through regulation is no longer a practical and viable way to administer the Federal Food, Drug, and Cosmetic Act. Over the past several years FDA has not been able to engage in substantial an important rulemaking in the public interest, e.g., the proposal, let alone promulgation of, current Good Manufacturing Practice regulations for dietary supplements. At the same time, the FDA has not used its law enforcement authority against companies whose conduct is contrary to the regulations that have been promulgated for this industry, e.g., regulations regarding structure and function claims for dietary supplements. Industry that wishes to comply with FDA requirements and consumers in general have not fared well in this absence of cGMP regulations and simple enforcement of regulations that have now been on the books for over two years. AHPA has supported and continues to support law enforcement as the tool that the FDA should use to advance the public health concerns that the Federal Food, Drug, and Cosmetic Act is designed to address.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? AHPA has described above in its response to FDA question 3 how FDA nutrient content claims regulations (21 C.F.R. 101.13 and 101.65), improperly circumscribe commercial speech regarding food and dietary supplement product content. In addition to the nutrient content claim regulations, Section 10806 of the Farm Security and Rural Investment Act of 2002 (Farm Bill), signed into law on May 13, 2002, amended the Federal Food, Drug, and Cosmetic Act to state that the term ginseng may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. In addition, this amendment states that only labeling or advertising for herbs or herbal ingredients classified with that genus may include the term ginseng. Finally, the amendment makes it a crime if a product purports to be or is represented as ginseng, unless it is an herb or herbal ingredient derived from a plant classified within the genus Panax. This section of the Farm Bill was supported by Senators Feingold and Kohl of Wisconsin and by Representative Obey of the same state. The amendment was requested by the Ginseng Board of Wisconsin, a state sponsored trade group of Wisconsin growers and marketers of American ginseng (Panax quinquefolius) and the intent of the law is clear, to make other herbs that are sometimes known as ginseng less competitive with American ginseng by making it a crime to use the name ginseng for any other herb. While AHPA worked with Senator Feingold's staff to assure that this language in the Farm Bill was carefully drawn to accomplish only the limited purpose of assuring that the common name ginseng was reserved to the genus Panax, AHPA did not endorse this legislation. Instead, AHPA has addressed this issue in its publication, Herbs of Commerce, 2nd edition (2000). That reference is consistent with Section 10806 of the Farm Bill, namely that only plants in the genus Panax use the term ginseng in their Standardized Common Names. Herbs of Commerce, 2nd edition is presently being considered for incorporation by reference by the Food and Drug Administration under 21 C.F.R. Sec. 101.4(h). The use of the term ginseng as part of the common name of plants of genera other than Panax is observed in trade from time to time. In most cases, these names are marginally used, either for herbs that are of limited market distribution or by only a minority of product vendors. The one exception to this is the common practice of identifying eleuthero (Eleutherococcus senticosus) as Siberian ginseng. Although some manufacturers now label their products containing eleuthero with the name eleuthero, it is a much more common industry practice to use the name Siberian ginseng. It is therefore that plant and marketers of that plant that will be most widely affected by the new law. Eleuthero is an important botanical in the United States market, as are the two principle species of Panax, specifically American ginseng (Panax quinquefolius) and Asian ginseng (Panax ginseng). According to data published by Nutrition Business Journal (NBJ), sales of ginseng were reported in 2000 to be $173 million, or 7.5% of all single herbal category sales of $2.3 billion. Because NBJ did not specify separately their estimate of sales for eleuthero products, it is not possible to know from the NBJ report what portion of this amount was actually reporting sales of eleuthero as opposed to sales of ginseng, that is, of products from the genus Panax. However, AHPA has contacted several of its members that sell products containing one or the other or both of these herbs. While we have not conducted a detailed market review of the relative sales of the ginsengs and eleuthero, it is certain that sales of eleuthero represent a significant portion, and perhaps half of all sales that have been historically recorded for ginseng. Shortly after this section became law, AHPA notified its members of the legislation and urged members to change product labels at the next printing. Nonetheless, AHPA must take the view that this legislation does not pass muster under the Supreme Court's decision in Thompson v. Western States Medical Center. The affect of the legislation is to deem, without inquiry, that the name Siberian ginseng is unlawful and misleading. But Congress made no reasoned determination in this regard. There is no substantial governmental interest barring the use of the name Siberian ginseng, a name that has been in use for almost 40 years, for this herb. And the statute is more extensive than necessary because if does not give companies a reasonable time to come into compliance. AHPA has therefore requested a moratorium on enforcement of the Farm Bill's ginseng section and the opportunity for AHPA and the herbal products industry to educate customers as to the fact that eleuthero is what has previously been marketed as Siberian ginseng as follows: A. Siberian ginseng labeled product - a period of one year from May 13, 2002, within which to run out inventories of products containing eleuthero that are presently labeled as Siberian ginseng. B. Eleuthero labeled product - a period of two years from May 13, 2002, within which to manufacture and ship products containing eleuthero that is labeled as eleuthero with parenthetical information that references the former name of Siberian ginseng (e.g., formerly known as Siberian ginseng, or formerly, Siberian ginseng). C. Eleuthero advertising - a period of two years from May 13, 2002, for manufacturers, distributors and retailers to advise consumers in advertising that eleuthero was formerly known as Siberian ginseng. While it is not shocking that narrow special interest legislation appears in a Farm Bill, it is surprising that it is found as an amendment to the Federal Food, Drug, and Cosmetic Act without hearing or discussion. AHPA respectfully suggest that enforcement of this provision must be tempered because of its failure to address the issues discussed above.




EC -429