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RETURN RECEIPT REQUESTED
 
WARNING LETTER
Ref. # DEN-17-04-WL
 
April 17, 2017
 
 
Darren Jensen
LifeVantage Corporation
9875 S. Monroe St
Suite 300
Sandy, UT 84070
 
 
Dear Mr. Jensen,       
                                   
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.nrf2science.com, www.lifevantage.com, and www.protandim.com in January 2017 and has determined that the claims on your websites establish that  your Protandim NRF2 Synergizer product is 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)(B)], because it is intended for use in the diagnosis, 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. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Examples of claims found on your websites that establish the intended use of your Protandim NRF2 Synergizer product as a drug include, but may not be limited to, the following:
 
On the www.nrf2science.com home page:
Under the “Nrf2 & the Body,” “Nervous System” tab, www.nrf2science.com/nervous-system:
Under the “Nrf2 & the Body,” “Cardiovascular System” tab, www.nrf2science.com,/cardiovascular-system/:
Under the “Nrf2 & the Body,” “Skin Health” tab, www.nrf2science.com,/skin-health/:
Under the “Cancer” tab, www.nrf2science.com,/cancer/:
Under the “Nrf2 Studies” tab, www.nrf2science.com,/studies/:
On the blog posts, www.protandim.com/blog/:
 
Under the April 1, 2012 post, “Long-Used, Much-Studied Turmeric a key Protandim Ingredient”:
Under the April 6, 2012 post, “Ultra-Popular Green Tea has its Place in Protandim”:
On the blog post, www.lifevantage.com/blog/study-confirms-protandim-nrf2-synergizer-extends-lifespan/:
 
Under the August 5, 2016 post, “Study Confirms Protandim Nrf2 Synergizer Extends Lifespan”:
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your product Protandim NRF2 Synergizer is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Furthermore, your product is intended for prevention of one or more diseases that are not amenable to prevention by consumers without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
The above violations are not meant to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your products comply with the Act and its implementing regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction. 
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which you will complete the corrections.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. Your written response should be sent to Nancy G. Schmidt, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Ms. Schmidt at (303) 236-3046 or by email at nancy.schmidt@fda.hhs.gov.
 
 
Sincerely,
/S/ 
LaTonya M. Mitchell
District Director
Denver District

This page was posted on November 14, 2018.

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