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Articles Tagged with ''warning letters''

4 Kratom Companies Sent FDA Warning Letters

July 6, 2022

Silver Spring, MD—On June 30, 2022, the Food and Drug Administration (FDA) issued warning letters, jointly with the Federal Trade Commission (FTC), to four companies selling kratom products. FDA stated that it has not approved kratom for the treatment or cure of opioid use disorder and withdrawal symptoms. FDA also...

FDA Retracts Warning Letter to Glanbia Performance Nutrition

May 12, 2022

WholeFoods Magazine Staff

Silver Spring, MD—On May 9, 2022, the Food and Drug Administration (FDA) announced that it had issued warning letters to 11 companies for selling adulterated dietary supplements. Listed among those 11 companies was Glanbia Performance Nutrition (Manufacturing) Inc., but in an updated announcement posted by FDA on May 10, 2022, Glanbia...

FDA Warns Companies on Adulterated Dietary Supplements

May 10, 2022

WholeFoods Magazine Staff

Update (May 10, 2022, 3:20 pm ET): FDA's original announcement on May 9, 2022, as reported in an earlier version of this article, listed Glanbia Performance Nutrition (Manufacturing) Inc. among the companies that received warning letters. In an updated announcement posted on May 10, 2022, Glanbia was removed from FDA's announcement, and is...

FDA Sends Warning Letters to CBD, Delta-8 THC Companies

May 4, 2022

WholeFoods Magazine Staff

Washington, D.C.—The U.S. Food and Drug Administration (FDA) announced that it has issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA said this is the first time warning letters...

FDA, FTC Send Warning Letters to 10 Companies over Diabetes Claims

September 9, 2021

Julia Peterman

Washington, D.C.—The FDA and FTC have posted warning letters to 10 companies for illegally selling dietary supplements claiming to cure, treat, mitigate, or prevent diabetes. "More than 34 million Americans— just over 1 in 10 people— are living with diabetes. Dietary supplements that make fraudulent claims to treat diabetes are...

FDA Warns 2 Companies for Misbranding Pain Relief Products Containing CBD

March 22, 2021

WholeFoods Magazine Staff

Silver Spring, MD—FDA has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the FD&C Act. Honest Globe Inc. and Biolyte Laboratories LLC have marketed pain relief products that the FDA is calling unapproved new drugs. Honest Globe was warned in...

FDA Warns Companies for Mental Health Claims

February 23, 2021

WholeFoods Magazine Staff

Silver Spring, MD—FDA has warned 10 companies for illegally selling supplements claiming to treat mental health disorders, according to a press release. The warning letters were issued to Enlifta LLC; Lifted Naturals; Mountain Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber’s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC...

FDA Sends Warning Letter to Amazon Associate

August 24, 2020

WholeFoods Magazine Staff

Silver Spring, MD—FDA has sent a warning letter to SilveryGuy, a website which encourages the use of colloidal silver for health benefits and pushes the sale thereof through Amazon Associate links, for making COVID-19 claims regarding a product the website was promoting. The warning letter explains that, as an Amazon...

AHPA Analyzes COVID-19 Warning Letters

June 17, 2020

WholeFoods Magazine Staff

Silver Spring, MD—The American Herbal Products Association (AHPA) has released its analysis of 135 COVID-19 related warning letters that were issued by either the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), or by the agencies jointly between March 6, 2020, and May 11, 2020. “The regulated dietary...

FTC Sends 35 More Letters to Companies With Unsubstantiated COVID-19 Claims

June 5, 2020

WholeFoods Magazine Staff

Washington, D.C.—The FTC has sent warning letters to 35 more marketers nationwide for making unsubstantiated claims that their products can treat or prevent COVID-19. This is the sixth set of warning letters FTC has sent. Most of the letters, according to an FTC press release, target “treatments” offered in clinics...