Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
September 25, 2014
VIA UPS OVERNIGHT
Attn: Tyler Boone
950 E. Harvard Avenue
Denver, CO 80210
REF #: DEN-14-13-WL
Dear Dr. Boone:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.multimmunity.com in July 2014 and has determined that you take orders there for the product Multimmunity, which the website promotes for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
In addition, we have reviewed the label for your Multimmunity product and determined that even if your Multimmunity product were not a drug, the product would be misbranded under section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]. You may find the Act and the implementing regulations on our website at www.fda.gov.
Unapproved New Drug
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
On the homepage:
- “[H]eart Health…A preventive non-drug approach to heart disease…”
- “[I]mmune Boost…Users…reported fewer colds…”
Under the heading, “Why Take Multimmunity?”:
- “Concussion Prevention/Recovery”
Under the heading, “Who Should Take Multimmunity?”:
- “Those with a Family History of Heart Disease, Cancer, or Diabetes”
- “Those Suffering from Hearing Loss…”
On the webpage titled, “Research”:
- “In 2007-2008, the MAVRIC Trial studied firefighters given one year of Multimmunity therapy, with no other medications. After one year, LDL-C (bad cholesterol) fell 20.80 mgdL (15.7%), while HDL-C (good cholesterol) increased a remarkable 8.83 mgdL (20.8%)…This study showed that Multimmunity works on its own as a heart health optimizer*. This type of product—a preventive non-drug approach to heart disease—is immensely valuable in the fight against the world’s number one killer.”
- “A study was conducted on U.S. soldiers recovering from concussions and persistent ringing in the ears due to blast injuries. Results have shown that supplementation with Multimmunity’s formulation in combination with standard therapy significantly improved treatment outcomes more than outcomes produced by standard therapy alone. The tremendous recovery results achieved piloted additional studies…[T]hrough the antioxidant saturation treatment of Multimmunity…concussion-related symptoms can be reduced, and significant levels of protection can be derived from Multimmunity for individuals at risk of high-volume or concussion exposure due to occupation or hobby.”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Multimunnity for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials appear on the webpage under the header “What Our Users Say” and include:
- “My doctor recently told me that…I was at risk for serious heart disease in the near future. As a part of his preventive treatment plan, my doctor recommended Multimmunity.” The testimonial also indicates that the product can be used for the symptoms of a family history of heart disease, high cholesterol, and high blood pressure and asserts that the benefits of the product include lowered cholesterol, reduced blood pressure, and reduced daily statin side-effects.
- “I suffered a sudden stroke in my 40s…Luckily, I found an amazing team of physicians to help me make a full recovery…I began to take Multimmunity to strengthen my cardiovascular system for the future.”
- “Earlier this year, I was diagnosed with Type I Diabetes…my physician recommended that I supplement my treatment with the Multimmunity formula, strengthen my cardiovascular system against this disease…I have taken Multimmunity ever since. It feels like this multivitamin was specifically made for me…Symptoms…Radiation Exposure…Type 1 Diabetes…”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 purposes. Thus, Multimmunity is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
Even if your Multimmunity product did not contain labeling claims that render the product a drug, the product would be a misbranded dietary supplement within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)] in that the product label does not include a statement of identity as a “dietary supplement” as required under 21 CFR 101.3(g).
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will make the correction.
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Nancy G. Schmidt, (compliance officer). If you have any questions concerning this letter, please contact Ms. Schmidt at 303-236-3046 or firstname.lastname@example.org.
LaTonya M. Mitchell
Denver District Director