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U.S. Department of Health and Human Services

Drugs

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Questions and Answers: Fraudulent STD Products Initiative

On May 3, 2011, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) jointly announced the Fraudulent STD Products Initiative.  This initiative targets over-the-counter (OTC) products (i.e. non-prescription), sold online and in some local retail stores that make unproven claims to prevent, cure, and/or treat sexually transmitted diseases (STDs). These products have not been evaluated by the FDA for safety and effectiveness. Currently there are no FDA-approved drugs, vaccines, or dietary supplements available over-the-counter (OTC) that can prevent or treat STDs. FDA-approved drugs and vaccines for the treatment and prevention of STDs can only be obtained by prescription through a licensed healthcare professional.

Q1. What are fraudulent STD products?
Q2. Why is FDA concerned about the use of fraudulent STD products?
Q3. How can consumers identify fraudulent STD products?
Q4. What should consumers do if they are currently using a fraudulent STD product or have used one in the past?
Q5. How will FDA and FTC remove fraudulent STD products from the market?  

Q1. What are fraudulent STD products?

A. Fraudulent STD products are products that make unproven claims to prevent, cure, and/or treat sexually transmitted diseases (STDs). Some of the products included in today’s action are marketed as dietary supplements and others are marketed as drugs.  Currently there are no FDA-approved drugs or dietary supplements available over-the-counter (OTC) that can prevent, cure, and/or treat STDs. Condoms are the only products cleared by FDA to help prevent sexually transmitted infections.  FDA-approved drugs and vaccines for the treatment and prevention of STDs can only be obtained by prescription through a licensed healthcare professional.

Fraudulent STD products are being sold primarily over the Internet, but some are also available in local retail stores. 

Marketers of fraudulent STD products are in violation of the Federal Food, Drug, and Cosmetic Act.  These products have not been evaluated by the FDA for safety and effectiveness and may pose health risks to consumers who are misled to believe they are receiving safe, effective treatment. In addition, marketers making scientifically unsupported claims that their products can effectively prevent, cure, or treat STDs are in violation of the Federal Trade Commission Act. 

Q2. Why is FDA concerned about the use of fraudulent STD products?

A.  FDA is concerned about the use of fraudulent STD products because they have not been evaluated by the Agency for safety and effectiveness.  Consumers who use fraudulent STD products may not seek the medical attention they need, delaying appropriate and effective treatment, and potentially spreading infections to sexual partners because they falsely believe they are being treated for their disease.

Q3. How can consumers identify fraudulent STD products?

A.  Consumers should know that there are no FDA-approved drugs, vaccines, or dietary supplements available over-the-counter (OTC) that can prevent, cure, and/or treat sexually transmitted diseases (STDs).  FDA-approved products for the treatment and prevention of STDs can only be obtained by prescription through a licensed healthcare professional.   Some fraudulent STD products that have been identified include H-Stop Dx, H-Guard Dx, Wart Dx, Molluscum Dx, EverCLR3, Herpeset, C-Cure, Viruxo, Medavir, and Wartrol.  The following table provides several manufacturers of these products and their websites, but this list is not all inclusive.

Manufacturer Name

Product Name

Immuneglory
(Arenvy Laboratories, Inc)

ImmuneGlory

Viruxo

Viruxo

Masterpeace, Inc.

Disintegrate Formula, Echinacea/Golden Seal, Detox Formula, Burdock Extract,

Int'l Inst of Holistic Health (doctorAJAdams)

Oil of Oregano P73 Physician’s Strength, Essaic Tonic Liquid Drops, Colloidal Silver 500ppm (Liquid)

gene-eden
PolyDNA

Gene-Eden

Pacific Naturals   

Herpeset, Wartrol

Derma Remedies 

H-Stop Dx, H-Guard Dx, Molluscum Dx, Wart Dx

Flor Nutraceuticals

Herpaflör Outbreak Response Topical Liquid, Herpaflör Outbreak Response Tablets, Herpaflör Outbreak Response Combo Pack, Herpaflör Daily Formula Tablets, Herpaflör Complete Package

Medavir

Medavir, ViraBalm, Vyristic Immune Support, Medavir H-Elimination Kit

Never An Outbreak

O2xygen Force (Oxygen Force/OxyForce), DMSO Cream, DMSO Roll-on, DMSO Cream w/Aloe, AlkaLife

EverCLR3

EverCLR3

Chlamydia-Clinic.com

C-Cure

Q4. What should consumers do if they are currently using a fraudulent STD product or have used one in the past?

A.  FDA advises consumers who believe they might have used or are currently using a fraudulent STD product to stop using and discard the product, and see a licensed health care professional since they might be at risk for having an STD.  Correct diagnosis and treatment of an STD requires the supervision of a trained healthcare professional.  FDA recommends consumers contact a healthcare professional if they have symptoms of an STD, believe they may have been exposed to an STD, and/or are using OTC products to treat symptoms of an STD.

Symptoms of common STDs include: pain or burning sensation during urination, pain during sexual intercourse, abdominal pain, abnormal discharge from the vagina or penis, abnormal vaginal bleeding, genital itching, genital warts, and/or blisters or sores in the genital area.  However, the majority of people with sexually transmitted infections have no symptoms, so consumers should talk to a healthcare professional about STD testing if they are sexually active, have unprotected sex, or have been exposed to a STD. 

There are several FDA-approved drugs and vaccines available to treat and prevent many STDs, and these products have met federal standards for safety, effectiveness, and quality and are only available by prescription through a licensed healthcare professional and pharmacy.

For more information on STD symptoms and treatment, visit the Centers for Disease Control and Prevention website at http://www.cdc.gov/std.

FDA urges both health care professionals and consumers to report harmful effects experienced from using fraudulent STD products to the FDA’s MedWatch Adverse Event Reporting program by doing one of the following:

  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

Q5. How are FDA and FTC addressing fraudulent STD products in the market?  

A.  FDA and FTC are working together to stop promotions of fraudulent STD products under the new, joint Fraudulent STD Products Initiative.  As the first step in this initiative, FDA and FTC issued multiple Warning Letters to manufacturers and other parties responsible for marketing fraudulent STD products.  FDA and FTC will monitor the firms’ responses to the Warning Letters and take appropriate action as needed.  Firms that do not correct the violations may face enforcement action, possible legal penalties, and criminal prosecution.  Additionally, FDA and FTC are warning consumers and healthcare professionals not to purchase or use these fraudulent STD products.