Week in supplements: FDA NAC deadline, Blackstone Labs

Various dietary supplements 2019

This is a big week for the U.S. dietary supplement sector—on the legal, legislative and regulatory fronts. Consider the following developments.

  • On Monday (Jan. 24), a federal judge granted leave, or permission, for Quincy Bioscience to file a motion for summary judgment against the Federal Trade Commission and office of the New York Attorney General.

For years, Quincy Bioscience, which markets a brain health supplement called Prevagen, has been fighting New York state and federal regulators over whether the company violated deceptive advertising laws.

By giving the company leave to file a motion for summary judgment, Quincy has an opportunity to convince the court there are no disputed issues of material facts and its advertising claims for Prevagen are substantiated, or “supported with competent and reliable scientific evidence.”

  • Tuesday (Jan. 25) was the deadline for stakeholders to submit comments to FDA in response to its request for information about the past use of NAC (N-acetyl-L-cysteine). FDA requested the first date NAC was marketed as a dietary supplement or as a food, the safe use of the ingredient in products marketed as a supplement, and any safety concerns.

FDA has asserted NAC cannot be lawfully marketed in a dietary supplement since the ingredient was first approved as a drug in 1963. Industry stakeholders point to NAC’s purported long history of safe use, its marketing in dietary supplements before enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and material distinctions between NAC supplements and the approved drug.

“In summary, as supported by decades of global experience with this amino acid precursor by multiple routes of administration, the overwhelming evidence regarding the safety and value of this dietary ingredient is irrefutable,” the American Association of Naturopathic Physicians wrote to FDA.

The comments submitted to FDA (as of Tuesday afternoon) also demonstrate the pharmaceutical industry is paying attention to the NAC issue and concerned about the agency protecting their investments in drug research.

“We request that FDA take the [drug] preclusion provision of Section 201(ff) of the Federal, Food, Drug, and Cosmetic Act seriously to protect the right of companies that have spent significant time and research to develop drugs products from competition from dietary supplements that are clearly new dietary ingredients [NDIs] that have never filed a new dietary ingredient notification [NDIN] prior to the institution of substantial clinical trials,” Lumicen Pharmaceuticals Inc., which has  proprietary anti-aging molecules, wrote to FDA.

  • On Thursday (Jan. 27), the co-founders of Blackstone Labs, a sports supplements brand, are scheduled to be sentenced after pleading guilty to two criminal counts in a 14-count indictment: introduction of unapproved new drugs into interstate commerce with intent to defraud and mislead, and conspiracy to distribute controlled substances.

Aaron Singerman and Phillip (“PJ”) Braun each face up to 13 years in prison. Blackstone Labs also is scheduled to be sentenced Thursday.

Others tied to Blackstone Labs and indicted by a grand jury await sentencing in February for committing federal crimes.

  • Also on Thursday, the California State Assembly is scheduled to vote on legislation that would impose age restrictions on weight loss and over-the-counter (OTC) diet pills, according to the Natural Products Association (NPA).

Last year, several industry trade organizations expressed their opposition to AB 1341. In an interview Tuesday (Jan. 25), Dan Fabricant of NPA described the bill as “unnecessary and complete overreach.”

AB 1341, nonetheless, has its supporters in the state assembly and elsewhere.

On Jan. 20, the Assembly Appropriations Committee voted 11 to 2 to move the bill forward. The Strategic Training Initiative for the Prevention of Eating Disorders, which has been advocating for the legislation, argues weight loss supplements are insufficiently regulated by FDA and leave young people susceptible to deceptive marketing claims.

Lawmakers in several other states, including Massachusetts, are considering similar bills.





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