Inspections, Compliance, Enforcement, and Criminal Investigations
Washington Homeopathic Products, Inc. 10/6/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Rockville MD 20857|
October 6, 2009
RETURN RECEIPT REQUESTED
Mr. James Hoyt
Washington Homeopathic Products, Inc.
P.O. Box 359
Great Cacapon, West Virginia 25422
Dear Mr. James Hoyt:
The Food and Drug Administration (FDA) has reviewed your website at Internet address www.homeopathyworks.com and has determined that Influenzinum 08-09 is being promoted for conditions that cause the product to be a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 USC 321(g)] and a biologic, as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 USC 262]. Influenzinum 08-09 is considered to be a drug because the therapeutic claims as shown on your website establish the product's intended use as a drug. We note that at least one component of the product is recognized in the Homeopathic Pharmacopeia of the United States (HPUS). Please be aware that a product's compliance with requirements of the HPUS does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.
Influenzinum 08-09 is a drug under section 201(g) of the FD&C Act. According to your website, the product contains influenzinum. This component is listed in the HPUS.
Examples of the claims on your website include: "It [Influenzinum] is used to treat flu symptoms and possibly prevent flu" (emphasis added).
Your website provides a mechanism for purchasing the product through the site. Specifically, the website ordering page offers shipping to addresses within the United States.
False or Misleading Information
The information on your website is false or misleading. For example, your website makes effectiveness claims, but it lacks adequate descriptions of the risks, warnings, and contraindications of your product. Consequently, your product is misbranded under sections 502(a), 502(f)(1), and 201(n) of the FD&C Act, and is marketed in violation of sections 301(a) and 301(b) of such Act.
Failure to Require Prescription
You have failed to require that your product be dispensed under a prescription from a duly licensed practitioner. Therefore, your product is misbranded under section 503(b)(1) of the FD&C Act, and is marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act.
For the reasons cited above, you should immediately discontinue any website claims that "It (Influenzinum) is used to treat flu symptoms and possibly prevent flu" (emphasis added) and remove from your websites all other promotional materials for products that contain the same or similar violative presentations.
This letter is not intended to be an all-inclusive review of your websites and products your firm may be marketing. It is your responsibility to ensure that all products marketed by your firm are in compliance with the FD&C and PHS Acts and their implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action such as seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM-610, 1401 Rockville Pike, Suite 100 N, Rockville, MD 20852-1448, Attention Mary A. Malarkey, Director, Office of Compliance and Biologics Quality.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research