Josh Long, Associate editorial director, Natural Products Insider

January 25, 2022

3 Min Read
Week in supplements: FDA NAC deadline, Blackstone Labs

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.

Related:Quincy Bioscience says Prevagen advertising claims are substantiated

“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.

Related:NAC supplements dispute raises crucial question over drug research

  • 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.

 

 

 

 

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

Subscribe and receive the latest insights on the health and nutrition industry.
Join 37,000+ members. Yes, it's completely free.

You May Also Like