Recalls and Warnings

Sundial Herbal Ordered to Halt Distribution of Products

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(Date Posted: 6/2/2020)

On June 1, 2020, a New York federal judge filed an order against two individuals doing business as Sundial Herbal Products to stop the company from distributing its products, which were found to be misbranded and promoted as drugs. The FDA previously warned Sundial Herbal Products for selling adulterated products, including Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Sundial Ashanti Weight Loss Energy Lifter, Appetite Suppresser, African ManBack Tonic, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites.

The court concluded that Sundial was making unsupported claims about their products and that the FDA had not approved any use for Sundial's products. The products were promoted with claims that they could treat various ailments including syphilis, cancer, and HIV/AIDS. 

In a news release about the decision, FDA Chief Counsel Stacy Amin stated, "Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. Making claims that unproven drugs can cure or prevent diseases places consumers' health at risk. We remain committed to pursuing and taking swift action against those who attempt to subvert the regulatory functions of the FDA by repeatedly disregarding the law and distributing unapproved products." 

Under the injunction, Sundial and the two individual defendants cannot receive, label, hold, or distribute drugs until steps are taken to ensure that all of their products comply with FDA requirements.

See Related Warnings:

Seller of Herbal Supplements and "Tonics" Warned For Manufacturing Violations and Drug Claims

Federal Court Shuts Down Three Supplement Companies With Serious Manufacturing Violations

Federal Court Shuts Down Two Supplement Companies Selling Weight, Joint Health and Other Supplements

Department of Justice Files Complaint to Shut Down Supplement Company

To read the FDA's press release, use the link below.

Federal judge enters order of permanent injunction against New York company for distributing unapproved drugs



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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