The Food and Drug Administration (FDA) is particular when it comes to body building products and any dietary supplements that are mislabeled or misbranded, as evident from their many warning letters and enforcement actions to companies out of compliance. Regulators have a fine focus on dietary supplement products that are mislabeled or misbranded, and brands must be careful when it comes to ingredients and classification as a supplement or food.
There are distinct labeling requirements for foods and dietary supplement products. Some of the common infractions that get firms into trouble include labeling a “beverage” or “bar” as a dietary supplement and using substances that do not meet the statutory definition of dietary ingredient in the dietary supplement. Very often, incorrect labeling is a red flag that brings FDA scrutiny. Brands must ensure that products are labeled correctly as a dietary supplement or a conventional food.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) explicitly forbids a dietary supplement from being “represented for use as a conventional food.” DSHEA requires dietary supplements be intended for consumption in small amounts. DSHEA specifies that the “dietary supplements” regulatory category includes only products intended for ingestion in tablet, capsule, powder, softgel, gelcap or liquid form. Further, liquid dietary supplements are to be ingested in daily quantities measured in drops or similar small units of measure but the FDA does not expand on what similar small measures would be.
In addition, there are right “major” food allergens that must be conspicuously declared on conventional food and dietary supplements when the product contains a major allergen. The “major” food allergens are milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. When there is an ingredient derived from one of these eight food allergen categories, the presence of the food allergen must be conspicuously declared on the label in one of two ways. Failure to declare the presence of a food allergen is the leading reason for FDA-ordered food recalls.
Dietary supplements containing an ingredient that is unsafe, or lacks evidence of safety, is considered an adulterated supplement. When a dietary supplement contains an ingredient that does not meet the statutory definition of a dietary ingredient, labeling of the product as a dietary supplement is considered misbranding. Under DSHEA, FDA has authority to remove adulterated and misbranded products from the market.
Over the past decade, FDA has sent Warning Letters to dietary supplement manufacturers, a large portion of whom are in the sports nutrition business, for their use of ingredients that do not meet the statutory definition of a dietary ingredient, ingredients that are new dietary ingredients for which an NDI Notification has not been submitted, or ingredients known to FDA to be a public health risk.
Have you been sent a warning letter by the FDA? or have any questions or concerns about how to be compliant? Send us an email and tell us about your experiences on this topic. The team at HawkScanner is available and ready to help you meet FDA guidelines with our Product Compliance Database.