During a recent review of the FDA’s Warning Letters, I was surprised to see some of the claims cited against dietary supplement manufacturers and marketers. Companies continue to make claims that the FDA has explicitly prohibited, and an official warning from the FDA leads to costly damage control as well as loss of credibility in the marketplace.
Companies continue to make claims that the FDA has explicitly prohibited, and an official warning from the FDA leads to costly damage control as well as loss of credibility in the marketplace.
The Dietary Supplement Health Education Act (DSHEA) was signed into law in 1994 and changed the way that dietary supplements are regulated and labeled. The FDA enforces DSHEA’s labeling regulations. In 2000, the FDA published its final rule in which it described types of claims that can be made on dietary supplement labels without prior agency review. Even though many of these claims are fairly well spelled out in the regulations, marketers and producers of dietary supplements continuously run afoul of the boundaries established by DSHEA.
Not just the label
It should be noted that the guidelines govern any statement or claim made about a dietary supplement, not just those on the label. The FDA imposes the same rules on all marketing material associated with the product, including flyers and product descriptions on websites.
The FDA allows a few kinds of claims on product labels, including structure-function claims. DSHEA specifically prohibits any disease claims; statements on dietary supplement labels cannot claim to cure, treat, correct, or prevent disease, nor can they imply the treatment of or prevention of a disease.
The rules limiting the types of claims that can be made are mandated even when research demonstrates that a particular supplement helps to “treat” or lessen a particular illness. Evidence of efficacy does not change the boundaries of which claims can and cannot be made about dietary supplements.
Examples of prohibited claims
A quick review of the FDA Warning Letters reveals the prevalence of prohibited claims on products in the marketplace. Dietary supplement companies are cited for using claims such as:
- Herbal and natural therapies can do wonders at preventing breast cancer and fibrocystic conditions
- Helps to clear respiratory challenges such as asthma, bronchitis, respiratory congestion and coughing
- Reduces the pain associated with arthritis
- The best herbal choice for hyperthyroidism
- For killing parasites in the intestine
FDA determined that all of these claims are overt or implied disease claims. The consequences of making a prohibited claim on a product are serious. Producers and marketers can be fined, forced to halt production, and prohibited from producing or selling that particular product ever again.
What is the difference between an allowed structure-function claim and a prohibited disease claim? As previously noted, a disease claim is one that claims or suggests treatment or prevention of an illness. A structure-function claim is defined as a statement that describes how a product acts to maintain a structure or function of the human body. Structure-function claims are intended to support a healthy body’s structure or function.
Examples of allowable structure-function claims
Examples of allowable structure-function claims in the Final Rule include:
- Helps promote digestion
- Calcium builds strong bones
- Supports mood
- Helps promote urinary tract health
- Promotes relaxation
- Helps maintain intestinal flora
- Helps maintain cardiovascular function and a healthy circulatory system
Many dietary supplements include helpful structure-function claims. With the large number of dietary supplement options in the marketplace, structure-function claims help customers narrow their focus, find the right products, and get the most benefit from their supplements.
When creating label claims and description content, take heed – the FDA will look to the context and the nature of the claim when determining whether a product statement is allowed. Thus, if you have a perfectly acceptable structure-function claim on the label, and then embed a barred disease claim in a product description on your website, you may find yourself with an FDA Warning Letter.
Food Labeling, 21 CFR Part 101 2016.
Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Final Rule, 65 Fed. Reg. 4 (Jan 6, 2000).