Great Lakes Gelatin Company

Warning LetterClosed

James Burkett President Great Lakes Gelatin Company 253 Commerce Dr., Ste 101 Grayslake , IL 60030 United StatesIssued May 10, 2021Office of Human and Animal Food Operations East-VI

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateMay 10, 2021

Product TypeDrugs

StatusClosed

Closeout LetterNov 5, 2021

Letter Details

Firm: Great Lakes Gelatin Company
Location: James Burkett President Great Lakes Gelatin Company 253 Commerce Dr., Ste 101 Grayslake , IL 60030 United States
FEI Number: N/A
Country: United States
Issue Date: May 10, 2021
Issuing Office: Office of Human and Animal Food Operations East-VI
Product Type: Drugs
Status: Closed
Closeout Letter: November 05, 2021

Summary

Great Lakes Gelatin Company was cited for marketing collagen hydrolysate and related products as drugs without FDA approval by making disease claims on their website and social media platforms, including claims that products could reduce joint pain and treat other conditions. The company violated the Federal Food, Drug, and Cosmetic Act by introducing these unapproved new drugs into interstate commerce and misbranding products intended for use in the cure, mitigation, treatment, or prevention of disease without proper drug classification and approval. The FDA's review of the company's website, Facebook, Pinterest, and YouTube channel between March and May 2021 identified multiple claims establishing the products' drug intent under section 201(g)(1)(B) of the Act.

Great Lakes Gelatin Company FDA Warning Letter, May 10, 2021