Crafting dietary supplement claims can often be tricky and nuanced. Some would say being able to develop compliant claims is a special art, requiring dancing a fine line between black and white allowable “structure/function” claims and those with less clear regulatory status. Inflammation claims are no exception and can cause a unique headache for dietary supplement manufacturers.
A compromise of the Dietary Supplement Health and Education Act of 1994 (DSHEA) was to permit supplements to make structure/function claims related to certain conditions associated with natural states of the body. Compliant structure/function claims will describe “non-disease”-related effects that a nutrient has on normal structures or functions in humans, such as “builds strong bones,” Or “maintains digestion,” respectively. However, structure/function claims cannot describe diseases or refer to characteristic signs or symptoms of a disease or class of diseases. For example, “reduces high blood sugar” would be considered a disease claim because it is a characteristic symptom of diabetes.
Typically, dietary supplement manufacturers have found refuge in verbs such as “supports,” “maintains,” and “regulates,” to suggest a supplement is only intended to assist with normal body function. However, general inflammation claims such as “anti-inflammatory properties,” or “supports normal inflammatory response” and “decrease inflammation naturally” have still come under scrutiny by FDA.
Even though inflammation is not necessarily related to a specific disease, FDA’s final rule on structure/function claims specifically identified inflammation as an inappropriate claim. Specifically, in the preamble, FDA took the position that the claims “improves joint mobility and reduces joint inflammation and pain” and “anti-inflammatory effect on the gastrointestinal tract”—as well as just the term “anti-inflammatory”—are strongly associated with diseases and would constitute disease claims.
FDA has been quick to enforce against these kinds of claims by consistently issuing warning letters to supplement companies for claiming inflammation benefits. Even general claims such as “anti-inflammatory” with no other disease context have been the subject of FDA warning letters.
While not expressly addressing inflammation, FDA agreed supplements may carry statements that characterize a documented mechanism of action by which a nutrient or ingredient acts to maintain structure or function, but only to the extent the statement does not imply a disease. Therefore, inflammation claims describing a mechanism of action that are clearly not related to a disease would carry the lowest risk of enforcement. An example is, “post exercise inflammation support.”
Beyond FDA’s strict standard on inflammation-related claims, supplement manufacturers must also satisfy the FTC’s substantiation standard for these types of claims. While FDA will target companies for making disease-related claims, FTC has also been known to target companies for making inflammation claims that are false and misleading due to lack of sufficient scientific support.
The two agencies operate pursuant to a Memorandum of Understanding (MOU), under which FDA exercises primary responsibility for regulating the labeling of supplements, including enforcing against disease claims suggesting the product is intended to be used as a drug. FTC has primary responsibility regarding the regulation of the truth or falsity of advertising. Often, FDA and FTC will work together and frequently coordinate on issuing joint warning letters.
For health-related claims such as inflammation support, FTC generally requires the advertiser possesses “competent and reliable scientific evidence.” This standard is broadly 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.”
As a general rule, well-controlled human clinical studies are the most reliable form of evidence. When using this standard, FTC often cites flaws in study designs that are not placebo-controlled or blinded as well as studies where the ingredient, formulation, dosage, route of administration, or population studied did not match that of the advertised products. While results obtained from in vitro, animal and epidemiological studies will also be examined, they alone are rarely considered adequate substantiation.
In April, FTC settled a case with a Florida-based company that touted its products as 100% effective at relieving inflammation and swelling, among other aggressive claims for inflammation and pain relief. The order imposed a US$3.93 million settlement, which will partially be suspended due to an inability to pay after the defendants pay $100,000. FTC has participated in joint FDA warning letters targeting companies that make “anti-inflammatory” disease claims without proper substantiation, which violate both FDA and FTC laws and regulations.
Supplement manufacturers should be extremely cautious when using any type of inflammation-related claim, especially unqualified claims even when the claim is generally soft like “inflammation support” since FDA is likely to interpret it as a disease claim. If manufacturers choose to mention any inflammatory benefit, it should be clearly tied to a non-disease state, such as “supports healthy inflammation following normal exercise.” Furthermore, to guard against scrutiny by FTC, manufacturers should at least have one methodologically sound and statistically significant (to the 95% confidence level) clinical study with results that translate into meaningful benefits for consumers at the formulation and dosing of the advertised supplement.
Suzanne Bassett, associate, Amin Talati Wasserman LLP, advises clients on compliance, enforcement and transactional matters subject to overlapping jurisdictions of the FDA, USDA, FTC and the U.S. Consumer Product Safety Commission (CPSC). Bassett’s experience extends to matters involving the DEA, U.S. Customs and Border Protection (CBP) and various state and municipal agencies.