Todd Harrison11.01.01
Reviewing Structure/ Function Claims
Still confusion about FDA rules.
By Todd Harrison
As the year comes to an end, it is time to look back and measure the significant developments within the industry and the agencies that regulate it. While the last two years gave us Pearson v. Shalala and a general guideline on structure/function claims, 2001 has not provided us with any significant new developments. The promise of releasing current good manufacturing practices for dietary supplements by the end of last year now appears to be delayed until the end of this year or early 2002. Even then, this will only be a proposed rule rather than a final regulation. The likely reason that the cGMP proposal is delayed is that the regulations too closely resembled a drug cGMP rather than food GMP.
Given the tragic events of September 11, it is now unclear how soon FDA will address these matters. The agency is now embroiled in issues related to bioterrorism and ensuring the safety of the U.S. food system. Thus, priorities are changing within the industry and it is unlikely that dietary supplement regulation is a priority. However, industry self-regulation should be at the top of the industry list.
One area where self-regulation is in the greatest need is the area of structure/function claims. As everyone knows, there are several different types of claims that may be made for dietary supplement products in the United States. These claims include:
- Overall health and well-being claims
- Structure/function claims
- Express disease claims
- Health claims
- Nutrient content claims.
However, not all of these claims may be legally made. Specifically, the label and labeling (which includes product brochures, catalogs and pamphlets) of dietary supplements may not legally bear an express disease claim unless FDA specifically permits the claim to be made. Express or implied disease-related claims made in advertising are subject to similar but not identical regulation. Specifically, FTC, not FDA, has general authority over advertising. In this regard, the mere mentioning of a disease in an advertisement is permissible as long as it is truthful and not misleading. This means the company making the claim must have proper substantiation for the claim. With regard to a health-related claim, proper substantiation means that the claim is supported by “competent and reliable” scientific evidence.
To avoid potential regulatory problems under FDA’s regulations, companies should avoid structure/function claims that suggest a nutrient-disease link (unless it is an approved “health claim”) by referring to a possible abnormal condition (e.g., “inflammation of the arterial wall”), and instead phrase the claims in a manner that assumes a properly functioning structure or function of the body (e.g., “helps maintain a healthy cardiovascular system”).
Terms such as “rebuild,” “correct,” “lower” and “decrease” should be avoided. Instead, use terms such as “maintain healthy,” “support healthy” and “promote optimum” when drafting structure/function claims. Such claims are often characterized by the use of the following phrases: “promotes the normal function,” “promotes optimum health,” “maintains the normal function,” “provides nutritional support for,” etc. Examples of structure/function claims that use those phrases effectively are “provides nutritional support for a healthy cardiovascular system,” “helps maintain cholesterol levels that are within the normal range,” “designed to provide optimal nutritional support for overall health and vitality” and “helps maintain blood sugar that is within the normal range.”
All claims, whether they appear on product labels and labeling or in advertising, must be properly substantiated prior to the time the claim is made. Substantiation means that the company has a reasonable basis to conclude that the claim is truthful and nonmisleading. To substantiate a claim for the health related benefits of a particular product, such as a dietary supplement, a company is required to have competent and reliable scientific evidence to support the claim.
The level of support necessary to substantiate a claim depends largely on the claim being made. Claims that expressly state the level of support (e.g., “ten studies show”) or suggest a certain level of support (e.g., “doctors agree”) must be supported by that level of evidence. More often than not, however, advertising claims will not suggest that a certain level of support exists for a claim. In this situation, the level of scientific support necessary to substantiate a claim depends on the amount of research experts in the field would consider adequate to establish the claim’s truthfulness. Indeed, although FTC states that the quality of a study matters more than the quantity of studies, it will be the unusual occasion that one or two small (e.g., less than 15 patients) well-controlled clinical studies of relatively short duration will be adequate to substantiate an unqualified dietary supplement structure/function claim (e.g., “helps support a healthy heart”).
The type of evidence used to substantiate a claim may vary. Generally, FDA and FTC prefer well-controlled human studies. However, animal studies and in vitro studies may be used to support a claim if experts in the field would consider them suitable substitutes for human studies. Often, epidemiological studies may be substituted for well-controlled human studies, especially when the study is supported by other scientific evidence such as an explanation of how the nutrient works in the body. Competent and reliable scientific evidence requires that the research be conducted in such a manner as to yield meaningful results. In other words, claims must be based on solid scientific research, rather than on personal opinions—even if the testimonial is true or it is the opinion of a physician.
Scientific evidence, however, cannot be viewed in a vacuum. This means a claim must be evaluated in light of the totality of the scientific evidence available at the time the claim is made. For example, it is likely that FTC would consider a claim based on one research study to be misleading if there are ten well-controlled studies that suggest the claim is not true. Indeed, in this situation, qualified language appearing in the claim such as “a recent study suggests” would unlikely remove the misleading nature of the claim, unless an equally prominent disclaimer informed the consumer that numerous studies suggest otherwise. NW