New Dietary Ingredients In Dietary Supplements And Their Health Claims
The historical precedent for dietary supplements was that they would only contain ingredients that were actively available in the food supply and now chemicals. However, this slowly changed over time and supplement manufacturers began to include items that are believed to have a health benefit, but were not part of U.S. diets in the past. Some examples of these new products are Chinese herbal medicine ingredients and Indian Ayurvedic ingredients that have been used in other cultures for centuries, but have never before been used in America. This is where New Dietary Ingredients (NDIs) originated.
The FDA now requires that any dietary supplement that includes an NDI must, at least 75 days before releasing it on the U.S. market, have the manufacturer of the product send certain documents to the FDA that verify the claims made about the product and explain how it can be assumed that the product is safe for consumption. If the proper paperwork is not completed, the FDA will confiscate shipments of the supplement upon arrival in America as “adulterated”. The process to obtain NDI notification is a bit of a challenge.
Some health claims for diet supplements are categorized as “qualifying” by the FDA. Basically, certain medications, foods, herbs, vitamins, minerals, etc. are already known to interact a specific way with one another in relation to illnesses and diseases. If there is no conclusive “proof” that any ingredient does not cure or treat any disease, then that supplement is therefore labeled as “unapproved” by the FDA. Specific claims of functionality, however “unapproved” as they may be, are still “allowed” by the FDA for sale as supplements in the U.S.
When a diet supplement states certain claims of “treatment,” or has any medications, the FDA’s inspection of such a supplement becomes much stricter, going much deeper into the manufacturer’s processing plant itself. Since many diet supplements cannot or will not go this extra length to meet these higher drug regulations, they choose the wording of their product labels very carefully to refrain from making such claims.
There are several websites that can be used to avoid triggering FDA trip-ups like FDAImports.com. These sites will also aid those who have been targeted by the FDA to meander their way through the process of offering legal supplements again.
FDAImports.com was founded by Benjamin L. England, Esq., a former FDA professional with 20 years of direct FDA experience, 17 years of which were obtained inside FDA. Mr. England is now a privately practicing FDA lawyer managing food, drug, medical device, cosmetic, and electronic product regulatory compliance, international trade and customs law. FDAImports.com specializes in making the complex understandable.
