Constructing a proper structure/function claim

You, a supplement marketer, have developed a new dietary supplement. It has a well-researched and effective formula, a flashy label and a catchy (and properly trademarked) name. Now, you need to pitch it to customers. To do that, you decide to put claims on your product’s label.

What claims will help give your product a successful launch? If you say, for example, your immune-support supplement will cure the common cold, you will probably sell plenty of product (assuming consumers believe you). That claim, however, may also catch the attention of FDA and/or FTC.

FDA regulates supplements as foods, rather than drugs. Federal law, therefore, generally prohibits supplements from bearing claims that would appear on drugs. FDA has warned numerous companies that have claimed their products treat or cure colds. Here, FDA could allege your cold-curing claim makes the product an unapproved new drug. Furthermore, if you made the claim in advertising, FTC could argue your claim is false and misleading. The agencies would demand that you immediately stop selling your product, and would seek for you to disgorge the profits you made. If you can’t claim your product cures the common cold, what can you claim on a supplement label?

There are three main types of label claims that marketers may make about their supplement products

1) Structure/function claims (and the related claims of general well-being and claims related to a nutrient deficiency disease)

2) Health claims (and qualified health claims)

3) Nutrient-content claims

Claims, especially structure/function claims, may help sell product. However, they may also invite regulatory action if improperly phrased or inadequately supported.

Structure/function claim or disease claim?

Structure/function claims describe a nutrient’s or dietary ingredient’s effect on or maintenance of the structure or function of the body—for example, “calcium builds strong bones" or “antioxidants maintain cell integrity." A disease claim is an express or implied claim to diagnose, mitigate, treat, cure or prevent a disease—for example, “zinc cures colds." Importantly, disease claims, though in some ways similar to structure/function claims, are excluded from the definition of structure/function claims.

Supplements are generally regulated as foods, but a supplement bearing a disease claim will be regulated as a drug (unless the claim is an authorized health claim for which the product qualifies). This distinction makes sense: Dietary supplements are supposed to supplement the diet and provide benefits through nutrition, while drugs are intended to treat or prevent diseases.

These definitions may seem straightforward, but the line between a structure/function claim and a disease claim is often blurry. FDA provides 10 criteria to help determine whether a claim is a disease claim. FDA also explains the criteria in a guidance document. In its guidance, even FDA recognized “[i]t may not be possible always to draw a bright line between structure/function and disease claims."

As a rule of thumb, however, structure/function claims focus on positive health, while disease claims expressly or by implication center on a negative disease condition. Compare “helps maintain cardiovascular function and a healthy circulatory system" to “relieves crushing chest pain." FDA has classified the former as a permitted structure/function claim and the latter as a disease claim. “Helps maintain cardiovascular function and a healthy circulatory system" focuses on a positive: good cardiovascular health. Conversely, “relieves crushing chest pain" focuses on a negative, and is suggestive of angina or a heart attack, which are disease conditions. And returning to the example in the introduction, “cures the common cold" would be a disease claim, while “supports the immune system" would be a structure/function claim. “Supports the immune system" properly focuses on positive health and does not expressly or by implication suggest an effect on a disease.

Other would-be structure/function claims FDA has found cross the line into disease-claim territory include “hangover relief," “dissolving fibrin and scar tissues in the lungs," and “may be very beneficial in easing pain from both osteo and rheumatoid arthritis." FDA has also addressed some less-than-borderline disease claims in its warning letters, including “DRUG RESISTENT [sic] MALARIA . . . CANCER SUPPORT: BRAIN (GLIOMAS), BREAST, COLON, DRUG RESISTANT CANCERS" and “cure and prevention for Ebola Virus."

Adequate substantiation

Assuming a product bears a proper structure/function claim and not a disease claim, supplement firms making these claims on their labels must still meet several requirements. While FDA does not preapprove structure/function claims, marketers must submit a notification to FDA that includes the text of the claim no later than 30 days after first marketing the supplement. Additionally, the label bearing the claim must include a “disclaimer" that FDA has not evaluated the claim, and the product is not intended to diagnose, treat, cure or prevent any disease. Finally, the marketer must possess substantiation that the claim is truthful and not misleading.

FDA and FTC share jurisdiction over ensuring supplement claims are truthful and not misleading. They work cooperatively in determining what level of “substantiation" is required for structure/function claims. FDA and FTC typically apply the standard of “competent and reliable scientific evidence" to these claims, which FTC case law has defined as “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."

At first glance (and second and third), the “competent and reliable scientific evidence" standard does not seem to be clear. And to complicate matters, the standard is still evolving. FTC has argued the standard requires at least two randomized and well-controlled human clinical trials (RCTs). Recent court decisions may cause FTC to reevaluate its position. The U.S. Court of Appeals for the D.C. Circuit held in POM Wonderful LLC v. FTC that FTC failed to adequately “justify a categorical floor of two RCTs for any and all disease claims." Further, the U.S. District Court for the District of New Jersey ruled in U.S. v. Bayer Corp. that “competent and reliable scientific evidence does not require drug-level clinical trials."

While the Bayer and POM decisions are a promising step toward a more flexible substantiation burden, they do not excuse inadequate substantiation. The substantiation standard may not be crystal clear, but it is clear that one or two animal studies on an ingredient in a supplement will not rise to the level of “competent and reliable scientific evidence." At a minimum, supplement firms should gather all of their evidence, studies and research into a substantiation dossier, and should consider having the dossier evaluated by an expert in the industry.

You made sure your immune-health supplement bears structure/function claims, and not disease claims. It doesn’t say “cures the common cold," but says “supports immune function." Your lawyer reviewed your label and agreed your claims do not qualify as disease claims. You submitted your structure/function notification to FDA and put the required disclaimer on your label. Further, you had a dietary supplement expert review the substantiation for your claims, and he provided you with a report detailing his opinion that they are substantiated.

By taking these actions, you have drastically reduced the risk that your product will draw attention from regulators, class-action attorneys, industry self-regulation groups and state attorneys general. The relatively small upfront cost of compliance will help to save you drastically heavier fees and judgments down the line. Rather than spending time and money fighting FDA, FTC and plaintiffs’ counsel, you can focus on building your brand.

This article is for information only, and is not to be construed as legal advice.

David Torreblanca, Esq., is a New York dietary supplement lawyer with the law firm Collins Gann McCloskey & Barry (supplementcounsel.com). Torreblanca serves the day-to-day legal needs of clients in the fields of sports nutrition, health and dietary supplements.