| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human ServicesDecember 14, 2011
WARNING LETTER NYK-2012-07
VIA UNITED PARCEL SERVICE
Nenningers Naturals, LLC
Attn: Dr. Steve Nenninger, Website Owner
17 Youngs Lane
East Setauket, NY 11733
Dear Dr. Nenninger:
The Food and Drug Administration (FDA) has reviewed your website at Internet address www.triplefludefense.com and has determined that “Triple Flu Defense” 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]. Triple Flu Defense 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.
Background
Triple Flu Defense is a drug under section 201(g) of the FD&C Act. According to your website, the product contains Influenzinum 30C. This component is listed in the HPUS.
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.
Examples of some of the claims observed on your website include:
On the homepage:
â–“Seasonal Defense”
â–“Relieves Flu Symptoms”
â–“Eases Flu Vaccine Side Effects”
â–“…[T]his product is of inestimable value in the prevention and mitigation of influenza.”
On the webpage titled, “Product Info”:
â–“Unique Homeopathic Formula Adjusted Each Year to Combat Current Season’s Flu Viruses”
On the webpage titled, “Frequently Asked Questions”:
â–“How does Triple Flu Defense work?”
“Triple Flu Defense is taken once per week for optimum defense throughout the flu season – October to May – and can be started at any time. If you are experiencing flu symptoms, it is taken 3 times per day until symptoms subside.”
â–“Can I take Triple Flu Defense with the flu vaccine?”
“Triple Flu Defense can also be used to alleviate side effects from the flu vaccine.”
In addition, your website includes claims in the form of testimonials that establish the intended use of your product as a drug. Examples of these testimonials include the following:
On the webpage titled, “Our Customers”:
â–“Triple Flu Defense is a much needed solution for patients who have reacted to the flu vaccine or the flu. One of my patients had Guillain-Barre syndrome after the flu last year. He endured a long and difficult recovery. This year he is taking Triple Flu Defense with the confidence that homeopathic remedies are the best guard against viral flu infections.”
â–“It really works. My husband didn’t take the formula and got sick and I didn’t. It has no side effects.”
â–“I have been around people with the flu and haven’t gotten sick since taking Triple Flu Defense.”
â–“…[Y]our Triple Flu Defense works great. My son had no reactions and did not catch the flu this year.”
â–“I swear by Dr. Nenninger’s Triple Flu Defense formula. It got me well, it got me better.”
â–“I had been sick for a week with the flu and thought I was never going to feel better. I took two doses of Triple Flu Defense and felt a lot better. It works great.”
â–“I'm one of the few people I know who didn't get the flu this past year because of Triple Flu Defense!”
â–“I took Triple Flu Defense during the season. I didn’t get sick all winter.”
We also note that FDA picked up promotional material titled, “A New Approach to the Flu” at the 2011 Natural Products Expo East trade show that was held on September 22-24, 2011 at the Baltimore Convention Center. Claims included in the promotional literature include the following:
In a text box featuring a testimonial which is also on the homepage of your website:
â–“…[T]his product is of inestimable value in the prevention and mitigation of influenza.”
Under the heading, “Reformulated Each Year”:
â–“…[W]e take the extra time and expense to reformulate each year for maximum effectiveness in fighting the current influenza viruses.”
Under the heading, “Unique Homeopathic Formula”:
â–“To relieve flu symptoms, it is taken 3 times per day.”
Claims on your website and product labeling that promote your product for use in the cure, mitigation, treatment, or prevention of disease may establish that your product is a drug. Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].
Moreover, we also note claims made on your Facebook account accessible at: https://www.facebook.com/#!/pages/Triple-Flu-Defense/144882121178
In a post on September 9, 2011:
â–“School has started! Now is the time to think about flu prevention. The new formula is out on the shelves at your local stores and practitioners offices. Start your weekly prevention dose now.”
This claim is also found on your Twitter account (@TripleFluDefens) accessible at: http://twitter.com/#!/triplefludefens
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. A new drug may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purpose. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
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 actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or E-mail at dean.rugnetta@fda.hhs.gov
Sincerely,
/s/
Ronald M. Pace
District Director
New York District
Strict guidelines are made for our own advantage and safety only.
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