The Regulatory Year in Review

An up and down year for the nutraceuticals industry.

By Todd Harrison

2000 is rapidly coming to an end and it is time to reflect on the past regulatory year. The year started off quickly with FDA issuing its final rule on structure/function claims for dietary supplements. At first blush, it appeared that the final rule would permit a vast array of claims, in­cluding claims previously reserved for OTC drug products, e.g., “the occasional re­lief of gas,” as well as claims regarding na­tural states, e.g., “PMS” or “meno­pause.” Unfortunately, the courtesy letters from FDA to companies since that time indicate otherwise. Indeed, in many instances, it appears that the courtesy letters directly contradict the final rule. For instance, FDA has objected to bone density claims because these claims imply that a particular nutrient or group of nutrients will help prevent or treat osteoporosis. FDA takes this position even though increasing or maintaining bone density is important to overall bone health and does not specifically refer to a disease or health-related condition.

FDA also continues to make distinctions that amount to no more than se­mantics. For example, FDA considers the claim “helps pro­mote healthy cholesterol levels” to be im­permissible, while it considers the claim “helps promote cholesterol levels that are al­ready normal” to be permissible. It is doubtful that consumers would attribute different meanings to these statements. Yet, the agency has decided to continue making these trivial distinctions, which only serves to further confuse companies as to what constitutes a permissible structure/function claim.

It has been argued that FDA’s restrictive approach to structure/function claims is directly related to the agency’s decision to permit its Center for Drug Evaluation and Research (“CDER”) to take the lead on this issue. While this argument may have some merit, it does not benefit industry to engage FDA in a battle over whether CDER is going to have any input. On the other hand, it does not benefit FDA to continually object to struc­ture/function claims that do not spe­cifically refer to a disease or health-related condition. This is especially true if FDA is unwilling to take enforcement action over the disputed claim or, more im­portantly, it is unlikely a court would sustain FDA’s objection if it decided to take enforcement action.

To avoid prolonging the debate over the permissible scope of structure/function claims, FDA needs to issue its draft guidance document and then engage in a constructive debate with industry before finalizing it (which it should have been publicly doing in the first place). FDA, however, should keep in mind that one of the express purposes of DSHEA was to permit truthful and nonmisleading structure/function claims and that it should not thwart the “will” of Congress by narrowly defining the permissible scope of these claims. Rather, FDA should take a practical approach to structure/function claims, i.e., if a claim can reasonably be interpreted, when viewed in context, to refer to the maintenance of a specific structure or function of the body, the claim should be permitted. Such an approach would help alleviate a lot of the confusion that now exists.

During the past year, FDA has also considered several issues associated with “health claims”—“claims that characterize the relationship of any substance to a disease or health-related condition.” Indeed, by the time you read this issue, FDA will have decided to either prohibit or permit, with or without disclaimers, the four Pearson health claims.

The Pearson decision, however, is only one part of the story regarding health claims. FDA also issued interim final rules regarding the relationship of stanol and sterol esters and coronary heart disease (CHD). However, the only dietary supplement products that would qualify for the claim are products that contain stanol esters in softgel form. Finally, FDA denied a health claim that described the relationship between saw palmetto and certain symptoms associated with BPH because the claim was a disease treatment claim rather than a disease reduction claim. One of the reasons FDA provided for denying the claim is that Congress intended to limit disease treatment claims to “medical foods.” While this argument has merit, the fact is that the Federal Food, Drug & Cosmetic Act does not specifically limit the scope of health claims to disease reduction claims. Thus, FDA may lose the pending litigation over its denial of the saw palmetto health claim. As to medical foods, FDA has provided no guidance regarding what would be required to substantiate that a particular food is a bona fide medical food. Given that FDA has raised this category of food as a reason for denying the saw palmetto health claim petition, it is time that FDA articulate its position.

FDA also responded this past May to inquiries regarding the marketing of OTC drug/dietary supplement products. While FDA raised certain safety and efficacy concerns in its initial pronouncements on this issue, FDA did not state that the marketing of such products is illegal. However, FDA has asked companies to refrain from marketing such products until such time that it has been able to fully consider the issue. Hopefully, FDA will issue its policy on this issue by the end of the year.

This year also saw FDA retreat somewhat from its proposed ephedrine rule. In particular, FDA withdrew its proposal to limit the amount of ephedrine alkaloids that could be present in dietary supplements. FDA also withdrew its limitations on duration of use and the type of claims that may be made for ephedrine alkaloid dietary supplements. However, FDA did not withdraw that part of the proposal that would prohibit combination ephedrine alkaloid/stimulant diet­ary ingredients (e.g., caffeine, yohimbe) dietary supplement products, nor did it withdraw the proposed rules requirement that a specific warning statement appear on the product label. It should be noted that FDA continues to gather evidence on the safety of ephedrine supplements, leaving open the possibility that the agency may re-propose dose, duration and claim limitations in the future.

FDA also won its appeal in Pharmanex v. Shalala. The case has now been sent back to the lower court for further consideration. The lower court will now have to consider whether the red yeast rice used in “Cho­lestin” is equivalent to lovastatin and, if so, whether it was marketed prior to lovastatin’s approval by FDA or prior to the initiation of substantial public clinical trials. The implication of this case is most likely limited. However, the court will likely have to pass on whether the presence of trivial or insignificant amounts of lovastatin in red yeast rice prior to lovastatin’s new drug approval permits the marketing of red yeast rice that has been standardized to contain significantly higher levels of lovastatin is permissible under DSHEA.

NW

Todd A. Harrison is a senior associate with the law firm Keller & Heckman, Washington D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on food and dietary supplement adulteration, labeling and advertising issues. He can be reached at Keller & Heckman, 1001 G. St. NW, Suite 500 W, Washington D.C. 20001; 202-434-4244; Fax: 202-434-4646; E-mail: [email protected].