Warning letterFDA · Mar 28, 2019
Named company: Nutra Pure LLC
In addition, the Federal Trade Commission (FTC) has reviewed your website for potential violations of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. 45(a) and 52. For example, two such substantial clinical…
Warning letterFDA · Mar 28, 2019
Named company: PotNetwork Holdings, Inc.
In addition, the Federal Trade Commission has reviewed your website for potential violations of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52. A drug is misbranded under section 502(f)(1) of…
Warning letterFDA · Mar 28, 2019
Named company: Advanced Spine and Pain, LLC (d/b/a Relievus)
FDA has determined that your “CBD Salve” and “CBD Oil” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C.…
Import alertFDA · Mar 26, 2019
Named company: ACDC KOZMETIK SANAYI VE TICARET A.S.
"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: ACDC…
Import alertFDA · Mar 26, 2019
Named company: Kingdom Honey SDN. BHD.
"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: Kingdom…
RecallFDA · Mar 19, 2019
Named company: Merical, LLC
Incorrect probiotic strain used in formulation which did not match product labeling.
Import alertFDA · Mar 18, 2019
Named company: Herbal Solutions Health, S.A. de C.V
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: Herbal Solutions Health, S.A. de C.V Date Published : 03/18/2019…
Import alertFDA · Mar 18, 2019
Named company: Herbal Solution's Health S.A. de C.V.
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP. Firm/address: Herbal Solution's Health S.A. de C.V. Date Published : 03/18/2019…
Warning letterFDA · Mar 5, 2019
Named company: Hanna's Herb Shop
Aside from risks like permanent damage to the liver, nervous system, and muscles other side effects include: Kidney failure, Amnesia, Homicidal impulses, Hostility, Short temper and irritability, Nausea,…
RecallFDA · Feb 28, 2019
Named company: Fungi Perfecti LLC
Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat.