Inspections, Compliance, Enforcement, and Criminal Investigations

MPH Nutrition LLC 10/1/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863 

 

October 1, 2015
 
WARNING LETTER
 
CHI-1-16
 
 
 
UPS NEXT DAY DELIVERY
SIGNATURE REQUIRED
 
Mike Harriet
MPH Nutrition, LLC
3023 N. Clark St., Suite 104
Chicago, IL 60657
 
Re: CMS# 476727
 
Dear Mr. Harriet:                                                                                           
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.remindrecover.com in August 2015 and has determined that you take orders there for your product, “Re:Mind Recover,” 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)(B)]. 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.
 
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include the following:
 
On the firm’s website, www.remindrecover.com, on the webpage titled, “The Science” under the heading, “How do Omega-3’s Support Healthy Brain Function?”:
 
In the video titled, “What role does nutrition and Omega-3's play in concussion recovery?”:
  • “…Omega-3 fatty acids are important for neurological recovery…” 
In the video titled, “Why are Omega-3's important for student athletes”:
  • “[C]an decrease the risk of future injury”
In the video titled, “Who recommends and uses Omega 3's for concussion recovery”:
  • “[T]he intake of omega-3 fatty acids into their concussion protocols.”
On the document posted on the webpage titled, “The Role of Omega-3’s in Concussion Recovery White Paper” which includes directions for use for consumers to take Re:Mind Recover for a brain injury:
  • “…[R]esearch by Michael Lewis, MD and others has shown that it is Best Practice for athletes to take high doses of high quality Omega-3’s to give their brain the building blocks that it needs recover after contact.”
  • “While no product can prevent or quickly heal a concussion, nutrition and Omega-3’s can play an important role in the recovery process.”
  • “Re:Mind Recover™ makes it easy for athletes to follow Michael Lewis, MD’s Omega-3 Protocol for Brain Injury to help support their recovery.”
  • “[T]o date there is limited experience with patients using this protocol for other medical conditions, including stroke, ADHD, depression, and other situations. However, initial research suggests that the brain may benefit from having more of the nutritional foundation provided by Omega-3's, like the high doses of high quality Omega-3’s found in Re:Mind Recover.”
  • “Growing amounts of clinical research suggests that Omega-3’s may be immensely useful in helping to decrease or eliminate many of the symptoms that plague patients following a concussion.”
  • “Drinking Re:Mind Recover™ provides a simple, safe and effective way to get the high dosage of high quality Omega-3’s athletes need…research has shown that Omega-3’s can play an important role in the recovery process.”
On the webpage titled, “Michael Lewis, MD’s Omega-3 Protocol for Brain Injury”:
  • “They designed their Re; Mind Recover omega-3 drink to make it easy for athletes and others to follow my Omega Protocol for Brain Injury…three times a day after a concussion. Can’t get more simple than that…”
Your Facebook page also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. The following is an example of such testimonial, which is endorsed or promoted by your firm:
 
Your firm “liked” the following visitor post dated July 27, 2015:
  • “For years I have been told that my brain will not heal and that I will be forced to deal with the lasting effects of my concussions. For the first time in a decade I believe that there is something that can help me, and that is Re:Mind Recover. I highly recommend this product to anyone that plays contact sports and has felt the lasting effects of a head injury. This product delivers more than relief from the effects of concussions, it provides hope that the brain can heal with the proper help. Thank you Re:Mind Recover.”
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, “Re:Mind Recover,” 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, “Re:Mind Recover” 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)].
 
The above violations are not meant to be an all-inclusive list of violations in your products or their labeling. 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 all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal 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 cited 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 within fifteen days, please explain the reason for the delay and the date by which the corrections will be completed.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA.
 
Please send your written reply to the Food and Drug Administration, Attention: Lauren Crivellone, Compliance Officer, 550 W. Jackson Blvd., Chicago Illinois 60661. Refer to the Unique Identification Number (CMS Case #476727) when replying. If you have questions about the content of this letter, please contact Ms. Crivellone at 312-596-4157 or e-mail lauren.crivellone@fda.hhs.gov.
 
 
Sincerely,
/S/ 
William R. Weissinger
District Director
 
 
cc:       
Luke Thiem
3023 N. Clark St., Suite 104
Chicago, IL 60657
 
Mike Harriet
3170 N. Sheridan Road, # 1218
Chicago, IL 60657

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