The Food & Drug Administration (FDA) takes action against dietary supplement companies for selling products identified as being “adulterated” or “misbranded.” The former is especially important because it involves the presence of ingredients not permitted for use in dietary supplements. Such ingredients have been found to be unsafe, lack evidence of safety, don’t meet the definition of a dietary ingredient, or combinations of these issues. Some are even used as drugs in other countries. Examples of these ingredients include Acacia rigidula, BMPEA, DMAA, DMBA, ephedra, methylsynephrine, and picamilon.
Adulterated and mislabeled dietary supplement products can pose risks to your health and your military career. Know what to look for!
The Federal Food, Drug, and Cosmetic Act (Title 21) strictly defines the terms “adulterated” and “misbranded” for foods, including dietary supplements, in great detail. With regard to the safety of dietary supplements, however, the most important points can be summarized as follows.
An adulterated dietary supplement is one that…
- contains any dietary ingredient that presents a risk to health when used as recommended.
- contains a new dietary ingredient lacking enough information to establish its safety.
- contains any ingredient declared by FDA to pose an “imminent hazard” to health.
- has been prepared, packed, or held under conditions that do not meet current good manufacturing practices.
Despite this federal law, adulterated dietary supplement products with ingredients prohibited for such use are relatively common. Military Service Members take note! Refer to the OPSS list of DoD-prohibited ingredients and FDA’s Dietary Supplement Ingredient Advisory List for some ingredients to watch out for.
A dietary supplement is mislabeled if…
- its labeling or advertising is false or misleading.
- its label doesn’t list the name of each ingredient and the quantity of each ingredient (or, for a proprietary blend of ingredients, the total amount of the ingredients in the blend).
- its label doesn’t include the words “dietary supplement” (or an acceptable equivalent, such as “herbal supplement” or “Vitamin C supplement”).
- it contains an herb or other botanical and fails to identify the part or parts of the plant from which the ingredient is derived.
- it fails to meet required standards of identity, strength, quality, purity, or compositional specifications.
- any required labeling is missing.
Mislabeling is a red flag that a supplement company also might not meet other federal requirements for safety and quality. For more information about dietary supplement labels, read the OPSS article about labeling requirements. For more information about FDA’s role in regulating dietary supplement products and ingredients, visit FDA’s web page.
Updated 26 March 2020