RecallFDA · Mar 8, 2021
Named company: New Generation Wellness Inc.
Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
Warning letterFDA · Mar 1, 2021
Named company: Cannafyl
The claims on your website and social media websites establish that all strengths and varieties of your “Balance CBD Drops,” 2 “Relief CBD Drops,” 3 “Relax CBD Drops,” 4 and “Relief CBD Salve” 5 (hereinafter…
Import alertFDA · Feb 22, 2021
Named company: JINGJIANG JIANGYANG FINE CHEMICALS CO.,LTD
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN NEW DIETARY INGREDIENTS. Firm/address: JINGJIANG JIANGYANG FINE CHEMICALS CO.,LTD Date Published :…
Import alertFDA · Feb 22, 2021
Named company: Suzhou Win Health International Co.,Ltd.
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN NEW DIETARY INGREDIENTS. Firm/address: Suzhou Win Health International Co.,Ltd. Date Published :…
Warning letterFDA · Feb 19, 2021
Named company: Richardson Nutritional Center, LLC/Nutriseeds, Inc.
Examples of some of the claims that provide evidence that your products are intended for use as drugs include the following: Regarding your Nutriseeds Fresh Bitter Apricot Seeds and Nutriseeds Natural…
Warning letterFDA · Feb 18, 2021
Named company: Lifted Naturals
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, your Mood Boosting Probiotic product fails to…
Warning letterFDA · Feb 18, 2021
Named company: Mercola.com, LLC
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 2pt1 U.S.C. § 355(a). Furthermore, these products are…
Warning letterFDA · Feb 16, 2021
Named company: KDunn and Associates, P.A. dba HealthQuilt
The investigational drug (b)(4) used in the study was an unapproved new drug, administered to human subjects (b)(4) for (b)(4) to treat, cure, and prevent COVID-19. (b)(4) is not a lawfully marketed drug…
Warning letterFDA · Feb 2, 2021
Named company: Clarke Pharmaceutical Manufacturing, Inc.
Food and Drug Administration (FDA) reviewed your website at the Internet address www.clarkepharmaceuticals.com in December 2020 and January 2021, and has determined that you take orders there for the products…
Warning letterFDA · Jan 25, 2021
Named company: PYRLess Group, LLC dba Dr. Fitt
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are…