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.
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 955-0316, Rpt. 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 PepZin GI™ in the United States.
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 PepZin GI™ 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.
After submission of the PepZin GI™ dossier on behalf of Hamari Chemicals, Ltd. in Canada, zinc carnosine is classified as a Natural Health Product (Natural Product Number 80054461) in October 2014 in Canada with a recommended daily dose of 150 mg per day (34 mg zinc) for zinc supplementation.
Zinc carnosine is listed in New Zealand’s Permitted Ingredient List and thus can be marketed.
After submission of the PepZin GI™ dossier on behalf of Hamari Chemicals, Ltd. in Australia, the Therapeutic Goods Administration (TGA) recognizes PepZin GI™ in October 2015 as a zinc supplement under Type 2 Simple Complementary Medicine Substance for products that contain low risk ingredients at a recommended maximum daily dose of 150 mg per day (34 mg zinc). This category encompasses medicines that are considered to be of relatively low risk compared to other types of medicines, such as prescription medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.
PepZin GI™ has been clinically evaluated in Japan for both safety and efficacy as a novel antiulcer agent and has been registered since July 1994 as an ethical drug for a clinical indication: the treatment of gastric ulcers at a use level of 150 mg per day (34 mg zinc).
Finished dosage forms containing zinc L-carnosine received market authorization in May 2009, approval from the Korea FDA as ethical drugs for gastric ulcer treatment, at a level of use of 150 mg per day.