FDA WARNING_LETTER - Great Lakes Gelatin Company - May 10, 2021

The FDA issued a Warning Letter to Great Lakes Gelatin after reviewing their website (www.greatlakesgelatin.com) and associated social media (Facebook, Pinterest, YouTube) from March to May 2021. The agency determined that the company's Collagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus products are marketed with claims that establish them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. These claims, found on product pages, blogs, videos, and social media, suggest the products are intended for the cure, mitigation, treatment, or prevention of various diseases, including reducing joint pain, acting as an anti-inflammatory, healing gastrointestinal lining, preventing stomach ulcers, and treating osteoporosis and osteoarthritis. Personal testimonials and scientific citations were also cited as evidence of intended drug use.

Because these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)]. Introducing such unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, the products are deemed misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because they lack adequate directions for use, as their intended purposes involve conditions not amenable to self-diagnosis or treatment by a layperson. The FDA requires Great Lakes Gelatin to respond in writing within fifteen working days, detailing specific corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to address these violations adequately may result in legal action, including seizure and injunction.