Recalls and Warnings

Seller of Vitamin D, MSM, Selenium & More Warned for Drug Claims

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If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem.
(Date Posted: 4/17/2020)

On March 31, 2020, the FDA issued a warning letter to KetoKerri LLC following a review of the company's website, which found statements made about some of the company's products, including Dr. Fitt Robynzyme, Level Up Clean MCT C8 Oil, KK Black Seed Oil, KK Breakthrough Vitamin D with CHONDROITIN & OLEIC, KK Clean Clay, KK EDTA with Selenium & Minerals, KK Humic/Fulvic Minerals & Electrolytes, and KK 99.9% Pure Organic Sulfur Crystals MSM to be drug claims.

For example, KK MSM was promoted with statements such as "People take MSM by mouth for chronic pain, osteoarthritis, joint inflammation, rheumatoid arthritis, osteoporosis, inflammation around the joints (bursitis), tendinitis, swelling around the tendons (tenosynovitis), musculoskeletal pain, muscle cramps, hardened skin condition called scleroderma... hair loss... eye inflammation... gum disease, wounds, cuts, and abrasions/accelerated wound healing, RA (rheumatoid arthritis), carpal tunnel syndrome, asthma, allergies, muscle cramps/pain... eczema, rosacea, psoriasis." 

See ConsumerLab.com's Joint Health Supplements Review, including glucosamine, chondroitin, MSM, and Boswellia, for tests of related products.

KK Black Seed Oil was promoted with statements such as "Black seed oil can act as an Antibacterial agent, Antiviral agent, Antifungal agent, Antiparasitic agent." 

See ConsumerLab.com's answer to the question What are the health benefits of black cumin seed (black seed) oil? for more information.

KK EDTA was promoted with statements such as "KK EDTA with Selenium and Minerals... Helpful for ASD, Alzheimer's, heart disease." 

See ConsumerLab.com's Selenium Supplements Review for tests of related products.

KK Breakthrough Vitamin D with CHONDROITIN & OLEIC was promoted with statements such as "The latest Breakthrough in Vitamin D supplementation... A Few Symptoms That May Indicate Vitamin D Deficiency:... Diarrhea... Inflammation... Fibromyalgia, [and] Chronic Fatigue Syndrome." 

See ConsumerLab.com's Vitamin D Review for tests of related products.

In addition, several of the products were found to be misbranded because the labels did not provide adequate information on safe use, as required by federal regulations.

See related warnings:

Seller of Apple Cider Vinegar, Joint Supplements & More Warned for Drug Claims

Seller of Maca Powder Warned for Drug Claims

Seller of Vitamin D, Omega-3's, Whey Protein & More Warned for Drug Claims

Seller of Supplements for Pain and Allergies Warned for Manufacturing Violations, Drug Claims

Seller of Coenzyme-A Warned For Making Drug Claims

Marketers of CellAssure and Cognify Settle FTC Charges of Deceptive Cancer Claims

To read the FDA's warning, use the link below.

Warning Letter: KetoKerri LLC



For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.


 

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