Found at the FDA site: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378845.htm
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 claim: Using a particular dietary supplement promotes faster healing times 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.
“As amazing as the marketing claims here are, the science doesn’t
support the use of any dietary supplements for the prevention of
concussions or the reduction of post-concussion symptoms that would
enable one to return to playing a sport faster,” says Daniel Fabricant,
Ph.D., director of FDA’s Division of Dietary Supplement Programs.
One of the first alarms raised about dietary supplements being promoted to treat TBI came from 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, a
hot-button issue,” says Jason Humbert, a senior regulatory manager with
FDA’s Office of Regulatory Affairs. “That sparked 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, products promising relief from TBIs tout the benefits of
ingredients such as turmeric and high levels of omega-3 fatty acids
derived from fish oil. Turmeric is an Indian spice in the ginger family.
For Omega-3, FDA has recommended a maximum daily level of 3 grams per
day from all sources due to possible problems with increased risk of
bleeding, increases in cholesterol and problems with controlling blood
sugar levels.
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,
the violations 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 Star Scientific, Inc., for marketing its product Anatabloc 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.”
