“There can be two companies making the same ingredient, and one cheats on filtration. Back in November 2017, the FDA issued import alerts to stop the shipments of Kratom from entering the US. “I can’t bring charges against a product for violating the dietary supplement rules if there’s no evidence that the product is being used in a dietary supplement,” Tave explained in the first of two phone interviews.Steven Tave oversees FDA’s Office of Dietary Supplement Programs. U.S. authorities traced an illness known as eosinophilia-myalgia syndrome (EMS) to contaminated L-tryptophan, an amino acid sold as a supplement.The Japanese manufacturer likely responsible for the illnesses, Showa Denko K.K., produced its ingredient “through a fermentation process involving In his letter to Tave, Bell cited the L-tryptophan calamity to highlight the potential harm to consumers if ingredient suppliers do not disclose their manufacturing processes to FDA in an NDIN.“It was later shown that changes to the manufacturing protocols made by this firm resulted in the production of many impurities that were not found in L-tryptophan manufactured using previously established protocols,” Bell wrote to Tave, in his request for the agency to issue an import alert. I’m just confused. U.S. authorities traced an illness known as eosinophilia-myalgia syndrome (EMS) to contaminated L-tryptophan, an amino acid sold as a supplement.The Japanese manufacturer likely responsible for the illnesses, Showa Denko K.K., produced its ingredient “through a fermentation process involving In his letter to Tave, Bell cited the L-tryptophan calamity to highlight the potential harm to consumers if ingredient suppliers do not disclose their manufacturing processes to FDA in an NDIN.“It was later shown that changes to the manufacturing protocols made by this firm resulted in the production of many impurities that were not found in L-tryptophan manufactured using previously established protocols,” Bell wrote to Tave, in his request for the agency to issue an import alert. We do not work for industry.”In an interview, attorney Scott Bass explained why, in his opinion, a “second comer” or “follow-on product” to an NDIN must also notify FDA. The first 2 numbers are the industry code of the product. A long-time FDA official, he was named ODSP’s first permanent director in November 2016 after serving as acting director beginning in March 2016.Addressing the level of detail FDA is seeking from an outside party that could support an enforcement action, Tave likened the process to writing a brief to a court in which the judge in her order essentially adopts verbatim the petitioning lawyer’s motion. “If we have sent letters like this, and received responses or not, we wouldn’t be able to discuss those because we only discuss the compliance status of a firm with that firm.”FDA suggested the prevalence of a regulatory pathway known as GRAS (generally recognized as safe) self-affirmation complicates its efforts to enforce compliance with a new dietary ingredient notification (NDIN) requirement in the Dietary Supplement Health and Education Act of 1994 (DSHEA).Manufacturers of conventional food have an option to inform FDA of their determination that an ingredient is GRAS, which provides the agency an opportunity to review the materials and raise issues that question the firm’s conclusion. Kratom is not used to treat, cure, or mitigate any disease, illness, ailment, and/or condition. The notification requirement is intended to give FDA the opportunity to review the identity and safety of an NDI.A proposal from Washington, D.C.-based attorney Scott Bass and physician Pieter Cohen of Harvard Medical School would largely gut the exemption in Section 413(a)(1)—what the authors described as a “loophole” that has “swallowed the law.” Manufacturers of supplements have used the exemption “to justify not submitting safety data to the FDA,” according to Cohen and Bass, a partner with Sidley Austin LLP, who helped negotiate DSHEA.DSHEA “was written with the expectation that this exemption would be used infrequently, but its language is not sufficiently clear,” the two men wrote in a paper published in December 2019 in the Firms reliant on GRAS self-affirmation don’t have to “notify FDA that they are doing so or share the basis for their conclusion,” FDA noted in an email to On its website, NAI described the ingredient as “an advanced delivery form of CarnoSyn, which delivers higher dosing levels of beta-alanine, and is proven to provide benefits for both wellness and healthy aging.” The company said the GRAS affirmation would allow it to broaden its “product offerings beyond the sports nutrition space and focus on the food and beverage industries, including medical and other fortified food products.”The announcement was made more than 18 months before NAI submitted its NDIN (Nov. 20, 2018) for CarnoSyn beta-alanine, which is distinguisable from SR CarnoSyn beta-alanine.NAI used the GRAS self-affirmation process for SR CarnoSyn beta-alanine, confirmed Kevin Bell, outside counsel to NAI and a partner with Arnall Golden Gregory LLP (AGG) in Washington, D.C. Naum, the FDA spokeswoman, verified the agency had no records of a GRAS submission for beta-alanine in its database.In a letter to Steven Tave, director of ODSP, Bell requested FDA issue an import alert, detaining beta-alanine manufactured in China that hasn’t been subject to an NDIN.