Mr. Christopher Jacob
CEO
Biomedical Research Laboratories, LLC
7590 Fay Ave Suite 202
La Jolla , CA 92037-4885
United StatesFEI 3017548891Issued Jul 1, 2021Office of Human and Animal Food Operations –West Division 5
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 3017548891.
Violations1
Issue DateJul 1, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Biomedical Research Laboratories, LLC
Location
Mr. Christopher Jacob
CEO
Biomedical Research Laboratories, LLC
7590 Fay Ave Suite 202
La Jolla , CA 92037-4885
United States
FEI Number
3017548891
Country
United States
Issue Date
July 01, 2021
Issuing Office
Office of Human and Animal Food Operations –West Division 5
Product Type
Drugs
Status
Open
Summary
Biomedical Research Laboratories, LLC was cited for marketing six dietary supplement products (Calm Legs, Flexify, Collagen Peptides, Prohemia, Altitude RX, and Trimmunity) as unapproved drugs through their websites without proper FDA authorization. The company violated the Federal Food, Drug, and Cosmetic Act by making disease claims—such as claiming Calm Legs provided relief from Restless Legs Syndrome symptoms—that established the products were intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. These products were introduced into interstate commerce without the required new drug applications and were misbranded under federal regulations.
Biomedical Research Laboratories, LLC FDA Warning Letter, July 1, 2021