In the new guidance on substances that can be added to foods, including beverages and dietary supplements, the FDA reminds manufacturers that the excipients added to oral dosage forms of these products need to “meet the same requirements as substances added to conventional foods.” This means that the substances added as fillers, coatings, antioxidants, disintegrants, etc. must be used either in accordance with a food additive regulation or be considered GRAS for the intended use. The only exceptions to the above are those substances excepted from the food additive definition.
The practice of relying on the presence of an excipient in the FDA’s Inactive Ingredient Database cannot assure that use of the same substance in a dietary supplement is acceptable. The risk-benefit balance accepted by the FDA for excipients in drugs is different than that for excipients in dietary supplements. For drugs, the FDA may find that short-term use or the serious nature of the disease a drug is intended to treat outweighs potential toxicity from an excipient. For dietary supplements, a similar level of excipient toxicity would not be tolerated when weighed against the potential for the long-term use of the supplement in a generally healthy population.
ProPharma Group is expert in assessing and qualifying the safety of excipients used in drugs and dietary supplements. Clients with questions are encouraged to call us to assist.
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