Guest post by Sarah Eliason
October 19, 2014
If you label your product as a dietary supplement, but claim that it can be consumed in any way other than oral ingestion, you may be at risk for a Warning Letter.
The Dietary Supplement Health and Education Act (DSHEA) defines a dietary supplement as a product that is “intended for ingestion.” Products cannot be labeled or marketed as dietary supplements if they use a delivery method that is not “ingestion” via an oral route.
What forms are allowed?
The typical forms—tablets, capsules, powders, softgels, gelcaps, and liquids—are allowed for dietary supplements. Other forms, like wafers or bars, can be considered dietary supplements, provided the form “is not represented as a conventional food and is not represented for use as a sole item of a meal or of the diet.” This means that the form may be considered a dietary supplement as long as it is not labeled or marketed to be used like a conventional food, or as a replacement for a conventional food.
What delivery methods are allowed?
The key word here is Ingestion. Ingestion via an oral route—swallowing into the stomach—is the only method of consumption for a dietary supplement.
What delivery methods are not allowed?
Since 2001, 39 Warning Letters mention products being marketed as dietary supplements that use delivery methods that are not “intended for ingestion”. These Warning Letters show that the following are not delivery routes for dietary supplements:
- Oral or Sublingual absorption (claiming that a product bypasses the digestive tract and is absorbed from the mouth directly into the bloodstream)
- Topical (including essential oils, sprays, creams, salves, ointments, wound dressings, skin patches, skin wipes, baths, and foot soaks)
- Inhalation
- Nasal spray or drops
- Ear drops
- Eye drops
- Rectal
- Vaginal
- Subcutaneous injection
As long as companies come up with new delivery methods, the examples of types of violations will continue to expand. Remember that when marketing a dietary supplement, the only delivery method is oral ingestion. Conversely, when labeling and marketing a topical product, don’t add any information that would be considered representation as a dietary supplement or food (any mention of internal use, a Supplement Facts or Nutrition Facts panel, DSHEA disclaimer, etc.).
Visit the FDA Warning Letters page for a full list of “intended for ingestion” violations here.
The complete statutory definition of a dietary supplement is found in section 201(ff) of Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) can be found here.
Sarah Eliason is a Senior Research Scientist at Nature’s Sunshine Products, Inc. With 14 years of experience in the dietary supplement industry, she specializes in technical writing and technical review.