Food supplements are rife in the American diet. Indeed, so many Americans expect supplements to do the heavy lifting of nutritional work in their diets that “substitute” might be a more accurate name.
But while many consumers see supplements as a quick fix or a panacea – and supplement manufacturers gladly reinforce this view through their labeling – the Food and Drug Administration (FDA) actually sets limits on the types of drugs. statements that supplement manufacturers can make. To ignore these limits is to run the significant risk of receiving a warning letter from the FDA. Warning letters are made public and receiving them can damage a manufacturer’s mark.
In February, the FDA announced that it had recently sent warning letters to 10 supplement manufacturers claiming that their products could treat or cure depression and other mental health disorders.
No dietary supplement, however effective, can contain a label claiming to “diagnose, mitigate, treat, cure or prevent” a disease.
Labeling is a broad term. This does not only apply to the physical label affixed to the container. It also applies to marketing materials accompanying the supplement or to statements made on the website selling the supplement. The FDA explains what types of statements will be considered inappropriate drug claims in Code of Federal Regulations, 21, 101.93 (g). A statement will be considered an inappropriate drug claim if it claims, explicitly or implicitly, that the product has an effect on a specific disease or class of diseases, or on their characteristic signs or symptoms, or on an abnormal condition associated with a disease. natural state or process, if this abnormal condition is rare or can cause significant or permanent damage.
In February, the FDA announced that it had recently sent warning letters to 10 companies for illegally selling dietary supplements due to unapproved claims.
A statement will also constitute an inappropriate drug claim if it claims that the product: belongs to a class of products intended to “diagnose, alleviate, treat, cure or prevent” a disease; is a substitute for a product which is a therapy for a disease; increases a particular therapy or drug; has a role in a body’s response to disease; treats, prevents or mitigates adverse events associated with a particular drug or therapy, if that adverse event is itself a disease; or otherwise suggests an effect on a disease.
So how can a dietary supplement manufacturer promote the health benefits of their products if they can’t make any of these claims? In general, there are three types of claims which do not infringe the regulations: classic claims relating to nutritional deficiencies; structure-function claims; and FDA approved health claims.
Let’s look at each of them in turn.
A classic nutrient deficiency is a disease or condition caused by a deficiency of a particular nutrient. Diseases such as pellagra and scurvy fall into this category.
The labeling of dietary supplements can inform consumers that the use of the product can cure or prevent conventional nutritional deficiencies if the manufacturer provides the FDA with a notice complying with the requirements of CFR, 21, 101.93 (a), within 30 days. after the product is first marketed, and if the product bears the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Section 101.93 (b) – (e) contains specific requirements regarding the location and prominence of the disclaimer.
Structure-function claims are also allowed. These types of claims suggest an effect of the product on the normal structure or function of the body. The emphasis here is on the use of the word normal.
So, rather than saying, for example, “This product prevents heart disease,” which is a clear example of an inappropriate drug claim, the labeling might say, “This product helps promote healthy heart function. Like conventional nutrient deficiency claims, however, the manufacturer must provide the required written notice to the FDA within 30 days, and also include the disclaimer.
The third type of admissible claim is an FDA approved health claim. Manufacturers can find these approved claims at CFR, 21, 101.72-83. An example of the type of health claim that is admissible would be a claim linking vitamin D or calcium to a reduced risk of osteoporosis. But if the FDA hasn’t approved a claim, the manufacturers may not say so, even though science shows it to be true. If a manufacturer thinks science supports the use of ginger root to reduce symptoms of Crohn’s disease, for example, they can’t make such a claim, even if it’s true, without asking the FDA to ‘approve such an allegation.
While it is true that dietary supplements are regulated more leniently than regular foods, this is not a license to sell unapproved drugs. Supplement manufacturers would be well advised to have their marketers work closely with legal counsel to develop labeling language that promotes the benefits of the product while remaining within FDA safeguards.