Recalls & Warnings
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Posted December 22, 2021
FDA Warns Seller of Liquid Magnesium, B-12, Berberine & More
On December 9, 2021, the FDA issued a warning letter to Wholly Liquid Nutritional Supplements LLC because it found statements on the company's website and social media about its products, including SpiroLaze, BioLaze, LiquiLaurin, VIT-B12, DeStress, and Omega Plus, to be drug claims.
For example, SpiroLaze, derived from berberine extract, was promoted with statements such as "Supports the Elimination of Lyme Bacteria" and "Benefits include anti-inflammatory properties,…speeding the physical process of healing, help for osteoporosis and osteopenia,...helps rid the body of chronic Lyme disease, Candida overgrowth, and helps Jaundice." The company's product BioLaze is promoted with similar statements such as "...useful for its anti-microbial properties which help neutralize Lyme neuro and biotoxins." And "Benefits include...the elimination of any bio or neurotoxins from any bacteria, mold, or other sources as well. It is an anti-inflammatory and anti-microbial formula that helps ulcers, stomach problems, mouth infections, diabetes, and high blood pressure, with antibiotic properties."
See ConsumerLab's Berberine and Goldenseal Supplements Review for information and tests of related products.
LiquiLaurin, made of magnesium citrate, organic coconut water, and more, is promoted with statements such as "...known to attack these pathogens including, but are not limited to: Borrelia burgdorferi and Borrelia garinii...Chlamydia...E.Coli" and "This formula is...powerful enough to help fight pathogens from viruses all the way to urinary tract infections."
VIT-B12 was promoted to "help with nerve damage in the hands or feet, sleep disorders, depression, mental disorders, inflammatory bowel disease, diarrhea, asthma, allergies, Lyme disease, and ringing in the ears." The company's DeStress product was promoted with similar statements, such as "Relieves...depression/anxiety symptoms..."
See ConsumerLab's B Vitamin Supplements Review and ConsumerLab's answer to What are the best supplements for depression and anxiety? for more information and tests of related products.
Omega Plus was promoted to "Reduce symptoms of ADHD," "Fight inflammation and pain," and "Help prevent cancer."
See ConsumerLab's Fish Oil, Krill Oil, and Algal Oil Omega-3 Supplements Review for the benefits of omega-3 and fish oil supplements, as well as tests of related products.
These products are intended for use in the cure, mitigation, treatment, or prevention of disease and are not recognized as safe and effective for the referenced uses, making them misbranded. The FDA advised Wholly Liquid Nutritional Supplements LLC to notify the agency in writing within 15 days of receipt of the warning letter outlining specific steps taken to address any violations.
For more information, use the link below.
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