Status of New Dietary Ingredients under The Food, Drug, And Cosmetic Act (FDC Act)
Ingredients that are legally defined as “new dietary ingredients” must be submitted or notified to the Food and Drug Administration (FDA) 75 days before being distributed or marketed in the United States. Under Section 402(f)(1)(B) of the FDC Act, failure to submit the 75-day notice to the FDA as required by 21 CFR Section 190.6 is a prohibited act that results in any product containing such new dietary ingredient being deemed adulterated under the FDC Act.
Additionally, each manufacturer or distributor has an individual responsibility to comply with Section 413 of the FDC Act and FDA regulation 21 CFR Section 190.6. Under 21 CFR Section 190.6, a “new dietary ingredient” submitted by one company does not provide a legal basis for another company’s reliance on that 75-day notice for legal marketing. An individual 75-day notice is not a generic filing for all subsequent companies marketing that “new dietary ingredient”.
New Dietary Ingredient Status of PepZinGI™
As required by Section 413 of the FDC Act and FDA regulation 21 CFR Section 190.6, a New Dietary Ingredient notification was filed on behalf of Hamari Chemicals Ltd. with the FDA on May 13, 2002 (See FDA docket 955-0316Rpt. 134). The FDA acknowledged receipt of the 75-day notification without comment on July 23, 2002 and accepted the use of PepzinGI™ as a source of zinc in dietary supplements in a targeted population of adults and children over the age of twelve. The 75-day notice submitted on behalf of Hamari Chemicals Ltd. and accepted by the FDA provides the regulatory basis for the legal sale and distribution of PepZinGI™ in the United States.
PepZinGI™ vs. Generic Zinc Carnosine
As presented above, the only Zinc Carnosine that meets the requirement of the FDC Act for the distribution and the sale in the United States is PepZinGI™ from Hamari Chemicals Ltd. Any other company distributing generic Zinc Carnosine in the United States that has not submitted the required 75-day notice for that particular ingredient with specified manufacturing specifications and indications of the intended and safe conditions of use is distributing a “new dietary ingredient” that is deemed adulterated under the FDC Act.
Any such use of that “new dietary ingredient” will also result in the product containing such ingredient to be legally considered adulterated under the FDC Act. Additionally, the use of “new dietary ingredients” in marketed products that violate the FDC Act has potential product liability exposure that must be carefully considered.