Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality

 

1401 Rockville Pike #200N, HFM-600
Rockville, MD 20852-1448

November 22, 2005
WARNING LETTER
VIA FEDERAL EXPRESS

George Luntz
NativeRemedies.com
1730 S Federal Hwy #253
Delray Beach, FL

Ref. No. 06-002

Dear Mr Luntz:

The Food and Drug Administration (FDA) has reviewed your website at Internet address www.nativeremedies.com and has determined that OralFlu Protect 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 (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]. OralFlu Protect is considered a drug because the therapeutic claims shown on your website establish the product's intended use as 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.

Background

OralFlu Protect is a drug under section 201(g) of the FD&C Act. According to your website the product contains influezinum and echinacea purpurea. These components are listed in the HPUS.

Examples of the claims observed on your website included:

Your website provides a mechanism for purchasing the product through the site. Specifically, the website checkout 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 numerous 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 violations of sections 301(a) and 301(b) of such Act.

Failure to Require a 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 offer to sell OralFlu Protect and remove from your website all other promotional materials for products that contains 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 US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM-600, 1401 Rockville Pike #200N, Rockville, MD 20852-1448, Attn: Mary A. Malarkey, Director, Office of Compliance and Biologics Quality.

Sincerely,
/s/
Mary A. Malarkey
Office Director

This page was posted on March 28, 2006.

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