The FDA has announced they will take regulatory action against 15 companies which currently sell illegally marketed diabetes products, according to an agency press release.
The foreign and domestic companies responsible for selling diabetes products online and in retail stores have been issued notification letters of federal violations, and the FDA is urging health care professionals to advise patients of the drugs’ potentially harmful ingredients.
“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments,” FDA Commissioner Margaret A. Hamburg, MD, said in a press release. “Consumers who buy violative products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management.”
According to the press release issued by the agency, illegally sold products include:
- Products sold as “natural” treatments for diabetes, but containing undeclared active pharmaceutical ingredients in unknown quantities that could cause harm or complicate medical conditions;
- Dietary supplements and ayurvedic products (medicine of the healing arts that originated in India) with claims to treat, cure and/or prevent diabetes;
- Unapproved drugs sold over-the-counter, including some homeopathic products intended to treat complications associated with diabetes, which include relieving symptoms caused by peripheral neuropathy; and
- Prescription drugs for diabetes sold by online pharmacies without a prescription.
Health care professionals are encouraged to report adverse events associated with these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For more information:
FDA Recall Notice. Accessed July 23, 2013.
FDA Consumer Update. Accessed July 23, 2013.