Import alertFDA · Feb 13, 2019
Named company: HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI
"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT". Firm/address: HAN ITHALAT…
RecallFDA · Feb 7, 2019
Named company: Kingston Pharma LLC
Presence of an undissolved ingredient, citrus flavonoid.
Warning letterFDA · Feb 5, 2019
Named company: DK Vitamins
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Ubiquinol CoQ10, Cognispark, Vinpurazine,…
Warning letterFDA · Feb 5, 2019
Named company: Nutrition Coalition Inc
Hyman suggests a combination of supplements that improve the body’s glutathione-producing ability[, including] … Alpha lipoic acid … milk thistle … Vitamins B-6, B-12, and folate … Vitamins C and E … Selenium”…
Warning letterFDA · Feb 5, 2019
Named company: Sovereign Laboratories, LLC
These include all auto-immune diseases including Crohn’s disease, diabetes, autism, lupus, multiple sclerosis, Alzheimer’s, Parkinson’s, arthritis, cholera, Salmonella and E. coli infection, HIV, arthritis,…
Warning letterFDA · Feb 5, 2019
Named company: Blue Ridge Silver
A recent study showed that people who had cases of gingivitis or periodontal disease tended to exhibit sings [sic] of early Alzheimer’s, dementia or extreme mental confusion.” “ . . . [G]ood oral health habits…
Warning letterFDA · Feb 5, 2019
Named company: Pure Nootropics, LLC
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Alpha GPC, Lion’s Mane, CDP Choline Capsules,…
Warning letterFDA · Feb 5, 2019
Named company: Peak Nootropics LLC (aka Advanced Nootropics)
The substance is believed to reduce the risk of ischemic stroke as well as minimize post-stroke damages to the brain. Early studies on the drug claim that it is a good supplement to consider for reducing the…
Warning letterFDA · Feb 5, 2019
Named company: Capris Associates Inc./BR Naturals
Monolaurin … was proven to help the immune system fight harmful viruses and bacteria (herpes, cytomegalovirus, influenza, HIV).” Additional examples of some of the claims and personal testimonials recommending…
Warning letterFDA · Feb 5, 2019
Named company: Earth Turns, LLC
On the webpage titled, “Pure Encapsulations – Green Tea Extract (Decaffeinated)”: “Green tea extract may also help to regulate blood sugar and reduce the risk of type 1 diabetes.” On the webpage titled, “How…