By Food and Drug Administration

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It’s back-to-school time, and kids are already starting practice for football, soccer and other sports. It’s a time when parents may be thinking about sport safety and the potential for their kids to be injured by violent jarring and shocks.

Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).

The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.

One common but misleading claim: Using a particular dietary supplement promotes faster healing after a concussion or other TBI.

Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.

"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."

A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.

A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.

“There is simply no scientific evidence to support the use of any dietary supplement for the prevention of concussions or the reduction of post-concussion symptoms that would allow athletes to return to play sooner,” said Charlotte Christin, acting director of FDA’s Division of Dietary Supplement Programs.

False Claims

One of the first alarms that dietary supplements are promoted to treat TBI was raised by the U.S. Department of Defense.

"We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, which is a hot-button issue," says Jason Humbert, a senior regulatory manager with FDA's Office of Regulatory Affairs. "That triggered our surveillance."

FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.

Typically, dietary supplements promising relief from TBIs tout the benefits of ingredients such as turmeric (an Indian spice in the ginger family) and high levels of omega-3 fatty acids derived from fish oil. In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have "the world's first supplement formulated specifically to assist concussion recovery," saying "it has the dynamic ability to minimize long-term effects and decrease recovery time." A National Football League player testified to its "proven results in my own recovery" from a concussion, and an unnamed "licensed trainer" said he had incorporated it into his "concussion management protocol."

Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, they could result in legal action taken without further notice, such as seizure or injunction.

Both companies changed their websites and labeling.

In December 2013, FDA issued a warning letter to another company for marketing its product with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.

"As we continue to work on this problem, we can't guarantee you won't see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them," says Coody. "If someone tells you otherwise, walk away."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

August 25, 2014

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FDA News Release

For Immediate Release: September 6, 2012
Media Inquiries: Tamara Ward, 301-796-7567, tamara.ward@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA issues warning letters to dietary supplement firms in Colorado and Texas for promoting unapproved products as drugs

The U.S. Food and Drug Administration today issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.

The products cited in the warning letters include Trinity Sports Group’s Neuro Impact Concussion Response Formula and PruTect Rx’s NeuroPruTect and Omega3PruTect. These products are in capsule and powder forms. They are marketed online in the United States and internationally.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. New drugs may not be legally marketed in the United States without prior FDA approval.  Although Neuro Impact, NeuroPruTect, and Omega3PruTect are marketed as dietary supplements, they are promoted as drugs through claims made on the firms’ websites.

“The FDA has taken these actions because companies may not sell new drugs unless the drugs have been tested by the sponsor and approved by FDA, and they may not make false or unsubstantiated claims about drugs they sell,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”

Neuro Impact, NeuroPruTect, and Omega3PruTect have not been approved by the FDA for treatment of concussions or for prevention or treatment of post-concussion syndrome or other neurological disorders, nor have the products been shown to be safe and effective for these purposes. Consumers should contact a physician or health care provider if they believe they have suffered a concussion, or if they have experienced any problems that may be related to taking or using these products.

MedWatch is the FDA’s program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online:www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. 
• Fax: 1-800-FDA-0178

For more information:

Warning Letters:

Prutect

Trinity Sports Group

Additional Information:

Health Fraud Scams

How Drugs are Developed and Approved

Dietary Supplements: What You Need to Know

Claims That Can Be Made for Conventional Foods and Dietary Supplements

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 09/06/2012 

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A 2013 warning letter

Star Scientific, Inc. 12/20/13

DEC 20, 2013

WARNING LETTER

VIA OVERNIGHT DELIVERY

Jonnie R. Williams, CEO

Star Scientific, Inc.

4470 Cox Rd., Suite 110

Glen Allen, VA 23060

Re: Case# 410094

Dear Mr. Williams:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites in December 2013 and has determined that you take orders for the product Anatabloc at www.anatabloc.com. This website, along with another website that you also operate, www.starscientific.com, promotes the product Anatabloc 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 these websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.

In addition, your Anatabloc and CigRx products contain anatabine as a dietary ingredient. While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket notification. To date, a premarket notification has not submitted to FDA, for your products containing anatabine; therefore, they are deemed to be adulterated. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Anatabine as a Dietary Ingredient

Your websites claim that Antabloc is a dietary supplement. Under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)], a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its investigation was authorized. According to your product labeling, your Anatabloc product contains anatabine. Anatabine became authorized for investigation as a new drug under an investigational new drug application (IND) that went into effect on June 8, 2012. According to press releases on your www.starscientific.com website, you began marketing CigRx, containing anatabine, on August 5, 2010, followed by Anatabloc, also containing anatabine, on August 11, 2011. Although these products were labeled and promoted as dietary supplements, they were not legally marketed as dietary supplements before the authorization of the IND because the products were adulterated due to the presence of anatabine, a new dietary ingredient that fails to meet the requirements of the Act, as explained below.

A dietary ingredient that was not marketed in the United States before October 15, 1994, is a new dietary ingredient under section 413(d) of the Act [21 U.S.C. § 350b(d)]. To the best of FDA’s knowledge, there is no information demonstrating that anatabine was marketed as a dietary ingredient in the United States before October 15, 1994. Therefore, anatabine would be a new dietary ingredient.

Under section 413(a) of the Act, a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:

1)      The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

2)      There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. 

To the best of FDA’s knowledge, there is no information demonstrating that anatabine has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. Although anatabine is present as an inherent constituent of foods such as cauliflower, eggplant, potatoes, and tomatoes, FDA is not aware of any information indicating that anatabine itself is an article used for food. In the absence of such information, anatabine is a new dietary ingredient subject to the premarket notification requirement in section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. 

Because the required premarket notification was not submitted to FDA, your products containing anatabine are deemed to be adulterated under section 413(a) of the Act and are prohibited from being marketed in the United States under sections 301(a) and (v) of the Act [21 U.S.C. §§ 331(a) and (v)].  Your unlawful marketing of the anatabine-containing products, CigRx and Anatabloc, does not constitute “market[ing] as a dietary supplement” within the meaning of section 201(ff)(3)(B) of the Act, and therefore these products were not legally marketed as a dietary supplement before the investigation of the new dietary ingredient they contain, antabine, was authorized under an IND. 

Anatabine as a Food

To the best of FDA’s knowledge, there is no information demonstrating that anatabine was marketed as a food prior to being authorized for investigation as a new drug under an IND. Although anatabine occurs naturally in certain foods such as cauliflower, eggplant, potatoes, and tomatoes, the mere presence of anatabine in such foods, without any evidence that the foods were promoted for their anatabine content, does not constitute “marketing” of anatabine as a food under section 201(ff)(3)(B). See Pharmanex v. Shalala, No. 2:97CV262K, 2001 U.S. Dist. LEXIS 4598 at *14-15 (D. Utah, March 30, 2001). Because anatabine was not lawfully marketed as a dietary supplement or as a food before it was authorized for investigation as a new drug, your Anatabloc product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the Act because it contains anatabine.

Anatabine in Tobacco

Further, based on statements on your website www.anatabloc.com that anatabine is one of the alkaloids found in tobacco and that anatabine has been shown to have anti-inflammatory effects in human epidemiological studies of tobacco alkaloid exposures, it appears that anatabine can be manufactured from tobacco. It is important to note that tobacco, including its constituents, is excluded from the definition of “dietary supplement” under section 201(ff)(1) of the Act. 

Unapproved New Drug

Your Anatabloc product is promoted for conditions which cause this product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The claims on your websites establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.

Examples of claims on your blog at www.anatabloc.com/category/health-research that provide evidence that your product Anatabloc is intended for use as a drug include the claims below. These claims also appear on your webpage “Newsroom-Press Releases” on your www.starscientific.com website.

“Star Scientific and Rock Creek Pharmaceuticals Report on the Beneficial Nutritional Effects of Anatabine in an Animal Model of Ulcerative Colitis”

• “Star Scientific, Inc. (STSI), through its wholly owned subsidiary, Rock Creek, Inc., announced today that it has received positive preliminary results from a study investigating the effects of anatabine in an animal model of idiopathic inflammatory bowel disease, Crohn’s disease and ulcerative colitis.”
• “[T]his model allowed for an examination of the effect of anatabine on the development and severity of inflammation (colitis prevention), as well as on the recovery from inflammation and repair of tissue damage (colitis treatment).”
• “The initial results of this study suggest that anatabine dietary supplementation may prevent the recurrence (flare up) of ulcerative colitis or reduce the severity of symptoms in vulnerable individuals.”
• “We…are very pleased with the results, which are consistent with the individual case reports of benefit we have received from physicians and patients describing their experiences with Anatabloc®.”

“Star Scientific Reports Publication of First Peer-Reviewed Article on the Effects of Anatabine in an Animal Model of Multiple Sclerosis”

• “Star Scientific, Inc. (STSI) today announces publication of the first peer- reviewed article examining the effects of anatabine in a mouse model of the debilitating autoimmune and neurodegenerative disease multiple sclerosis (MS).”
• “[O]rally administered anatabine significantly reduced neurological disability and improved motor coordination of EAE mice. In particular, paralysis of the hind limbs was markedly suppressed in the anatabine treated group, and neurological symptoms were delayed in the anatabine group compared to the placebo group.”
• “[A]natabine reduced the infiltration of inflammatory cells in the brain and significantly prevented demyelination in the spinal cord of EAE mice. In humans, demyelination of the spinal cord is associated with muscle weakness and paralysis in MS. Therefore, the researchers concluded that the ‘data suggests that anatabine may be effective in the treatment of MS.’”
• “[The author added] ‘The oral administration of anatabine potently reduced the neurological deficits and abrogated the pathological lesions in the spinal cord that are responsible for the development of paralysis in this mouse model of multiple sclerosis (MS).’”
• “This study builds upon earlier research conducted by the Roskamp Institute, which showed that the natural alkaloid anatabine displays anti-inflammatory properties and readily crosses the blood brain barrier, suggesting it could represent an important compound for mitigating many types of neuro-inflammatory conditions.”

“Research Published in European Journal of Pharmacology Shows that Star Scientific’s Anatabine Suppresses Brain Inflammation in Animal Model of Alzheimer’s Disease and in Blood”

• “[A]natabine can suppress brain inflammation in animal models of Alzheimer’s disease….”
• “[I]n a mouse model of Alzheimer’s disease, supplementation with anatabine resulted in a significant suppression of inflammatory markers, especially a marker called TNF-Alpha, which is known to be raised in Alzheimer’s disease. This finding compliments a previous study… showing reduction of the amyloid protein in this mouse model of Alzheimer’s after treatment with anatabine.”
• “Given the commonality of inflammatory systems in rodents and humans, there’s much reason to expect that anatabine will demonstrate similar properties in humans.”
• “[A]natabine may be a useful treatment for Alzheimer’s disease.”
• “[A] human clinical trial analyzing the effects of supplementation with Star Scientific’s anatabine compound on individuals with mild to moderate Alzheimer’s disease is currently in progress….”

Your product Anatabloc 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.

Examples of additional claims on your “Press Release – 2012 Archives” webpage of your website www.starscientific.com that provide evidence that Anatabloc is intended for use as a drug are provided below. These articles also are available via a link on your webpage http://anatabloc.com/category/health-research/.

“Research Presented at Neuroscience 2012 Indicates Anatabine Supplementation is Potentially Helpful in Recovery from Traumatic Brain Injury”

• “Star Scientific, Inc. (NASDAQ: STSI) through its wholly owned subsidiary, Rock Creek Pharmaceuticals Inc., reports that scientists…presented new research…indicating that supplementation with anatabine, the active ingredient in the Company’s Anatabloc® dietary supplement, has the potential to alleviate the negative consequences of traumatic brain injury (TBI).”
• “The scientists at the Roskamp Institute hypothesize that the maintenance of normal memory in TBI mice treated with anatabine is due to an inhibition of inflammation…‘[A]natadine treatment appeared to completely prevent the loss of spatial memory retention following TBI.’”
• “In addition to the TBI research, the Roskamp Institute presented results of its research examining the potential benefit of anatabine for alleviating symptoms associated with Multiple Sclerosis and will present new research on anatabine’s effect on Alzheimer’s disease….”

“New Research on Anatabine’s Beneficial Effect on Alzheimer’s Disease Presented at Neuroscience 2012”

• “[S]cientists from its research partner, the Roskamp Institute, presented research this week showing that anatabine supplementation reduces the pathology and signs in an animal model of Alzheimer’s disease.”
• “Last year, the Company reported the publication of the first peer-reviewed article on the in-vitro and in-vivo activity of anatabine in Alzheimer’s Disease in the European Journal of Pharmacology (Paris et al. 2011 Sept 19).”
• “In addition to the research on Alzheimer’s disease, earlier in the conference, the Roskamp Institute presented results of research examining the potential benefit of anatabine for alleviating symptoms associated with multiple sclerosis and in helping with recovery from traumatic brain injury.”

Finally, your “News/Articles” webpage www.starscientific.com/news-new-articles includes a link to an article entitled “Some Clues to the Prevention and Treatment of TBI,” which further discusses the Roskamp Institute’s research on anatabine and contains statements suggesting that anatabine may be useful in preventing and treating traumatic brain injury. Examples of these statements are provided below. Your use of this article to promote your product Anatabloc is further evidence that Anatabloc is intended for use as a drug. 

• “Given that inflammatory pathways are so significantly affected…a researcher at the Roskamp Institute[] wondered if some of the long-term damage, particularly memory problems, could be avoided by using a compound that dampens the brain’s natural inflammatory response. She and her colleagues had already found evidence that anatabine, a dietary supplement found in tobacco leaves, tomatoes, and eggplant, was a powerful anti-inflammatory agent.”
• “The group compared mice with brain injuries after being given anatabine versus a placebo…the mice who had received the anatabine after TBI performed as well as uninjured mice.”
• “’The anatabine appears to mitigate the neurobehavioral deficits that were the consequence of the head injury,’ says [the researcher].”

Your product Anatabloc 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, this drug 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 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 these violations may result in regulatory action without further notice, such as seizure and/or injunction.

In addition to the violations listed above, we offer the following comment regarding customer testimonials. In August 2013, we reviewed your website www.anatabloctrial.com, which now redirects to www.anatabloc.com, but which formerly offered free samples of Anatabloc to consumers who filled out an online form. In addition, the www.anatabloctrial.com website included a series of customer testimonials regarding purported benefits of Anatabloc in treating or preventing various diseases. For example, one testimonial stated: “Began taking anatabine because of its antidepressant quality, and it is good at that, for those who may need it…[W]ithin hours my lifelong severe sinusitis began clearing up…Next day I noticed a difference in my asthma (about 50% improved long term).” We note that the webpage containing the testimonials remains available on the Web at www.anatabloctrial.com/assets/anatabloc/testimonial.html, although this page no longer links to www.anatabloc.com. Like direct claims, testimonials on a manufacturer or distributor’s website recommending or describing the use of a product such as Anatabloc for the cure, mitigation, treatment, or prevention of disease are evidence of the product’s intended use as a drug. We advise you to review all websites you operate and remove any testimonials promoting your products for disease uses. 

Within 15 working days from receipt of this letter, please notify this office in writing as to the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of any related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections

Your written response should be directed to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), Division of Enforcement, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions regarding this letter, please contact Ms. Robinson at 240-402-1890 or by email at Latasha.Robinson@fda.hhs.gov.

Sincerely,

/S/                                                           

Charlotte Christin

Acting Director

Office of Compliance

Center for Food Safety

      and Applied Nutrition

cc:

Rock Creek Pharmaceuticals, Inc.,

55 Blackburn Center

Gloucester, MA 01930

FDA Baltimore District Office 

Page Last Updated: 01/13/2014