|Company:||Trinity Sports Group, Inc.|
|Issuer:||Dallas District Office|
|Issued:||Aug. 28, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
August 28, 2012
Walter Joseph Ford, BS, DC, CCSP
Trinity Sports Group, Inc.
2004 Ventura Dr.
Plano, TX 75093
Dear Dr. Ford:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites, www.neuroimpact.net and www.trinitysportsgroupinc.com, in June 2012 and has determined that your "Neuro Impact Concussion Response Formula" product is promoted 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 claims on your websites and the name of your product, "Neuro Impact Concussion Response Formula," establish that your product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act. You can find the Act and FDA's regulations through links in FDA's home page at www.fda.gov .
Examples of some of the claims observed on your websites include the following:
• "NEURO-IMPACT IS ... FORMULA TED SPECIFICALLY FOR CONCUSSION RECOVERY."
• "Neuro-Impact, developed to help those who suffer a concussion recover more rapidly ... to minimize long-term effects and decrease recovery time."
Your websites also contain disease claims in the form of celebrity and health professional endorsements, including:
• "Sammy Morris/NFL Running Back: 'Having suffered from a concussion, ... Neuro-Impact ... has proven results in my own recovery and is invaluable to all athletes, at all levels of sport, for recovering safely and quickly.'"
• "'The only tools we have been able to use for concussions are rest and time, but with Neuro-Impact we have something we can give that will help ... in the recovery process. Having used it on our athletes I have seen how well it works and have incorporated it into my concussion management protocol.' - ... , Licensed Athletic Trainer"
Under the heading, "Informational Downloads,"
In the document titled, "The Neuro-Metabolic Concussion":
• "By promoting a proactive, natural, safe protocol [Neuro-Impact], we can reduce healing time and limit further damage to the brain. In doing this, we ... decrease the degenerative nature of concussions and therefore decrease future neurological issues..."
In the document titled, "Neuro-Impact Formula Development":
• "Neuro-Impact, the world's first concussion response formula"
• "An effective and ... safe formula [Neuro-Impact], [Dr. Ford] began clinical tests . . . [T]rials included MTBI [Mild Traumatic Brain Injuries] and concussions ... Neuro-Impact has shown great results in decreasing recovery time and the time it takes to return to normal neurological function, including reaction time and relief of symptoms.''
• "Neuro-Impact is to concussion treatment ... essential"
In the document titled, "Neuro-Impact Ingredients & Dosage":
(The ingredient Vitamin C): "Anti-inflammatory"
(The ingredient Ginkgo Biloba): "assists with tennitis[sic]; decreases inflammation" . . .
(The ingredient PABA): "Anti-inflammatory"
(The ingredient Alpha Lipoic Acid): "decreases inflammation"
(The ingredient Bromelain): "decreases thrombosis and decreases inflammation; reduces edema"
(The ingredient Bilberry Extract): "reduces inflammation"
(The ingredient Huperzine A): "decreases ... brain cell damage"
(The ingredient "Tumeric" [sic]): "Decreases enzymes that cause inflammation"
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)]. New drugs 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 purposes. 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)].
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and 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. We advise you. to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. 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.
In addition to the previously quoted claims from your websites www.neuroimpact.net and www.trinitysportsgroupinc.com, we observed the following therapeutic claims on your Facebook account, "Neuro-Impact Concussion Response Formula," accessed at www.facebook.com/neuroimpact:
In the "About" section:
• "Neuro-Impact is the world[']s first supplement formulated specifically to assist concussion recovery. Developed to help those who suffer a concussion recover more rapidly ... Neuro-Impact has the dynamic ability to minimize long-term effects and decrease recovery time ... "
From your April 8, 2012 response to a comment on your Timeline post dated April 7, 2012:
• "[T]his product is formulated to work for those suffering from a concussion."
From your Timeline post dated April 3, 2012:
• "[I]n the first two days of [Neuro Impact's] availability, we have treated 3 soccer concussions, 3 gymnastic concussions, and 1 hockey concussion."
We also observed the following therapeutic claims on your Twitter account (@Neuroimpact), accessed at https://twitter.\com/neuroimpact:
In your post dated March 8, 2012:
• "Something more than the "wait and see" treatment needs to be done. NeuroImpact is that something. #concussion"
In your post dated March 1, 2012:
• "[W]e can help with Kobe's concussion and every other concussion. Would love to show you how. @NeuroImpact"
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. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen days, explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention of Thao Ta, Compliance Officer, Food and Drug Administration, Dallas District Office: 4040 North Central Expressway, Suite 300, Dallas, Texas 75204.
If you have any questions regarding this letter. please contact Mr. Ta at (214) 253-5217.
Reynaldo R. Rodriguez, Jr
Dallas District Director