JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health

Warning LetterOpen

Jeffrey Neil Burgee CEO JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health 1309 ½ S. Roxbury Dr. Los Angeles , CA 90035 United StatesFEI 3017548889Issued May 26, 2021Office of Human and Animal Food Operations- West Division 5

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017548889.

Violations1

Issue DateMay 26, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
Location: Jeffrey Neil Burgee CEO JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health 1309 ½ S. Roxbury Dr. Los Angeles , CA 90035 United States
FEI Number: 3017548889
Country: United States
Issue Date: May 26, 2021
Issuing Office: Office of Human and Animal Food Operations- West Division 5
Product Type: Drugs
Status: Open

Summary

JLM Nutritionals, Inc. was cited for marketing five nutritional supplement products (IBSolution, Premium Probiotic, Sleep Solution, Joint Solution, and Ultra Omega Fish Oil) as unapproved drugs through their websites, Amazon, and Facebook pages. The company made disease claims that established the products as drugs under federal law, including statements that IBSolution was "designed to relieve Irritable Bowel Syndrome (IBS) symptoms including diarrhea and constipation" and claims about clinical trial evidence for symptom relief. These marketing claims violated the Federal Food, Drug, and Cosmetic Act by introducing drug products into interstate commerce without FDA approval and proper drug labeling.

JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health FDA Warning Letter, May 26, 2021