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U.S. Department of Health and Human Services

International Programs

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Unapproved Over-the-Counter (OTC) Products Containing Human Chorionic Gonadotropin (HCG)

 

December 15, 2011

 

Dear International Colleague,
 

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued Warning Letters to seven U.S. companies that are marketing unapproved over-the-counter (OTC) products containing human chorionic gonadotropin (HCG) that are labeled as “homeopathic” for weight loss. The unapproved homeopathic HCG products are marketed in U.S. retail outlets and through websites accessible worldwide, in the form of oral drops, pellets, and sprays. The FDA has not evaluated these products for safety or effectiveness.

HCG is a hormone that the FDA has approved as an injectable prescription drug for treating select cases of female infertility and hormone treatments in men. However, the FDA has not approved HCG products for weight loss.

The Warning Letters, jointly issued by FDA and FTC on November 28, 2011, inform the U.S. companies that they are violating federal law by selling unapproved new drugs and misbranded drugs, as well as by making unsupported claims about the products they market. These companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited in the Warning Letter. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.

Consumers and health care professionals are encouraged to report possible related side effects from the use of these products to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

You may find additional information about this action at the following FDA websites:

Warning Letters:

The Warning Letters are posted at the following web site:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/default.htm

  • Nutri Fusion Systems LLC
  • Natural Medical Supply
  • HCG Platinum, LLC
  • theoriginalhcgdrops.com and resetthebody.com
  • HCG Diet Direct, LLC
  • hcg-miracleweightloss.com
  • HCG 1234 LLC (dba The hCG Drops LLC)

Consumer Update: “HCG Diet Products Are Illegal”
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm

Fraudulent HCG Products for Weight Loss:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm282465.htm

If you have any questions about this matter, please contact our Office of International Programs at + 1 301-796-4600 or at OIPCommunications@fda.hhs.gov. I also stand ready to assist you; please contact me at MaryLou.Valdez@fda.hhs.gov.

  

Sincerely,

---/s/---

Mary Lou Valdez, MSM
Associate Commissioner for International Programs

 

 

International Outreach to Foreign Embassies

 

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