Biomedical Research Laboratories, LLC
FDA issued a warning letter to Biomedical Research Laboratories, LLC (CEO Christopher Jacob) in July 2021 after reviewing the company's websites and social media, finding that six products — Calm Legs, Flexify, Collagen Peptides, Prohemia, Altitude RX, and Trimmunity — were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The claims included treating Restless Legs Syndrome, arthritis, anemia, acute mountain sickness, and immune conditions. FDA also found Calm Legs, Collagen Peptides, and Flexify to be misbranded because adequate directions for layperson use could not be written for prescription-level conditions. The company was required to respond within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (22)
Calm Legs is a safe, natural remedy that has helped thousands of people relax and get a good night's sleep. Order Calm Legs today for rapid relief from RLS...
Our scientists used the most potent compounds available in amounts shown to prevent symptoms of Acute Mountain Sickness.
A 2015 study found that adding type II collagen from chicken [an ingredient in Collagen Peptides] to the diet of people with rheumatoid arthritis was effective in reducing pain, stiffness and swelling of joints.
Calm Legs is the only RLS natural supplement that contains the seven natural ingredients clinically proven to relieve RLS symptoms.
Calm Legs provides natural relief from the jumpy legs and fatigue associated with RLS.
Ginger [an ingredient in Flexify] has been shown to work about as well as ibuprofen when taken daily for hip and knee arthritis pain.
Both human and animal studies have suggested that echinacea [an ingredient in Trimmunity] stimulates immune function and activates natural killer cells.
The active components in Altitude RX have been demonstrated to increase oxygen levels and reduce symptoms of Acute Mountain Sickness.
Used consistently, Flexify will help alleviate painful joint stiffness, joint discomfort... If you are experiencing pain in your elbows, knees, hips, thumbs, shoulders or fingers, you can expect relief from aches and soreness...
Flexify Advanced Joint Support is used by athletes and others affected by arthritis... Each tablet contains seven clinically tested, natural ingredients that help build and maintain healthy joints and cartilage, slowing the progression of osteoarthritis or preventing it completely.
CALM LEGS IS THE SOLUTION FOR RESTLESS LEGS!
Prohemia, promotes red blood cell production, . . . promotes hemoglobin production, and improves energy level and stamina in individuals with anemia.
Each ingredient in the Calm Legs formula has been clinically tested and shown to reduce symptoms of RLS.
For many users, Calm Legs brings rapid relief from Restless Legs Syndrome...
Discover how the ingredients and vitamins in Calm Legs help reduce the symptoms of restless leg syndrome where other prescription drug therapies fall short.
Mom had a stroke on Procrit. Since starting Prohemia she has not needed any more transfusions. Her hemoglobin went from 9.3 G/dL to 11.8 g/dL.
Glucosamine, chondroitin, and MSM [ingredients in Flexify] are well-studied ingredients for...relief from arthritis.
Here's the real breakthrough: A specific combination of these natural compounds taken in precise ratios appears to unlock lasting RLS relief. This combination is found in Calm Legs.
Altitude RX is designed to safely and significantly increase oxygen levels at high altitude…
Prohemia helps support healthy blood levels in individuals suffering from symptoms associated with anemia.
[E]lderberry [an ingredient in Trimmunity] is most often used to alleviate seasonal illness and respiratory challenges.
Research suggests that collagen peptide supplementation may also be effective in reducing pain and inflammation associated with chronic conditions like osteoarthritis.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.
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