- Issuing Office:
- Center for Biologics Evaluation and Research
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Silver Spring, MD 20993 |
July 6, 2015
VIA UPS AND EMAIL
Ratis, LLC Jeffrey Kagan
106 Old Court Road, Suite 104
Baltimore, MD 21208
Dear Mr. Kagan:
The Food and Drug Administration (FDA) has reviewed your website at Internet address http://www.homeopathystore.com/collections/allergies-cold-flu and has determined that Influenzinum 9C (2014-2015) and Influenzinum & Thymuline Combo, are 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]. The products listed above are considered drugs because the therapeutic claims as shown on your website establish the product's intended use as a drug. We note that Influenzium 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 is a drug under section 201(g) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man. Additionally, it is a drug under 201(g) because according to your website, the product contains influenzinum. This component is listed in the HPUS.
Some examples of the claims on your website include:
Influenzinum 9C (2014-2015)
• "…prevent the flu” (emphasis added).
• “…avoid vaccinations with conventional needles and potential harmful side effects” (emphasis added).
• “Proven highly effective in helping you resist the season's flu strains, Influenzinum 9C (2014-2015) is an excellent flu shot alternative” (emphasis added).
• “If you are thinking about getting the Influenza vaccine but do not want to be vaccinated with conventional needles or are concerned about potential vaccine side- effects, Influenzinum 2014-2015 is an excellent choice for flu prevention” (emphasis added).
• “Take 3 pellets of Influenzinum 2014-2015 once a week during the winter months to prevent the flu” (emphasis added).
Influenzinum & Thymuline Combo
• “The combo is also a highly recommended alternative to conventional flu shots” (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. Furthermore, its labeling fails to bear adequate directions for use. 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 statements on your website making the claims described above and you should remove from your websites all other promotional materials for products that contain the same or similar violative presentations.
We recognize that your product is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. Your product is a drug under section 201(g) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man. Additionally, the definition of “drug” in Section 201(g)(1) of the FD&C Act includes articles recognized in the HPUS, or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed. Thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with Section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self- diagnosis (of symptoms) and treatment may be marketed over-the-counter (OTC). Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
This letter is not intended to be an all-inclusive review of your website 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 following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, 10903 New Hampshire Avenue, Building 71, Silver Spring, MD 20993, Attention LT Shannon Aldrich, Regulatory Review Officer.
If you have any questions regarding this matter, you may contact the Division of Case Management at (240) 402-9155. Please be advised that only written communications are considered official.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
211 E Lombard Street, Suite 303
Baltimore, MD 21202