FDA cracks down on illegal concussion claims
SILVER SPRING, Md. — The Food and Drug Administration is cracking down on companies claiming their products can speed recovery from concussions, according to a consumer update posted Wednesday.
"The Food and Drug Administration 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 stated. "The agency also is warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat or cure concussions and other traumatic brain injuries 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 are marketed to consumers using social media, including Facebook and Twitter."
One common claim is that 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," stated 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," he said. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
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 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," added Daniel Fabricant, 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," said Jason Humbert, a senior regulatory manager with FDA’s Office of Regulatory Affairs. "That sparked our surveillance."
Typically, products promising relief from TBIs tout the benefits of such ingredients as turmeric and high levels of omega-3 fatty acids derived from fish oil.
In December 2013, FDA issued a warning letter to Star Scientific for marketing its product Anatabloc with claims to treat TBIs.
NBTY donates nearly $7 million in products, money throughout 2013
RONKONKOMA, N.Y. — In 2013, NBTY supported more than 30 organizations, including Feed The Children and International Aid, with nearly $7 million in products and money to provide sustenance, nutrition and support to those who need it most, the supplement manufacturer announced Thursday.
NBTY’s donations to Feed The Children are estimated to have reached almost 450,000 beneficiaries, the company stated.
In addition, for the seventh year, NBTY manufactured and packaged a proprietary blend of vitamins to be distributed worldwide through Vitamin Angels. In 2013, NBTY provided Vitamin Angels with enough children’s chewable daily multivitamins to reach nearly 123,000 children in 23 countries, including 18 U.S. states.
Also in 2013, NBTY Helping Hands supported a variety of organizations, including Long Island Cares, 9-1-1 Veterans, Big Brothers Big Sisters, Long Island Blood Services and the Ski’s Open Heart Foundation. The organization purchased, filled and donated more than 3,000 backpacks to help underprivileged children return back to school in the fall. Donations allowed Long Island Cares to build a new facility in Lindenhurst, N.Y., provided scholarships to children through Big Brothers Big Sisters and provided Thanksgiving meals to veterans and their families for the holidays through 9-1-1 Veterans.
"All of us at NBTY take a great deal of pride in being able to reach out and support our local and global communities in such a profound way," stated Jeff Nagel, CEO of NBTY. "Beyond our products, our associates donate their own time and effort to make many of these donations possible and to figure out ways to give back. We are a company that believes in wellness, and I’m proud that we are able to truly get behind our wellness mission by helping others."
Study: Researchers find that committing to quit smoking every Monday improves success rate
SAN DIEGO — According to a recent study published in the Journal of Clinical Psychology, 120 million Americans will make New Year’s resolutions, with such health-related goals as quitting smoking topping the list.
Unfortunately, most of those quitters will be puffing away by Groundhog Day.
Instead of encouraging smokers to plan one quit attempt around New Year’s, which comes only once a year, experts believe a better strategy would be to follow a New Year’s quit with a weekly recommitment to quit that takes advantage of natural weekly cycles.
In a 2013 study published Friday in JAMA Internal Medicine, researchers from San Diego State University, the Santa Fe Institute The Monday Campaigns and the Johns Hopkins Bloomberg School of Public Health monitored global Google search query logs from 2008 to 2012 in English, French, Chinese, Portuguese, Russian and Spanish for searches related to quitting, such as "help quit smoking," to examine weekly patterns in smoking cessation contemplations for the first time. The study found that people search about quitting smoking more often early in the week, with the highest query volumes on Mondays. This pattern was consistent across all six languages, suggesting a global predisposition to thinking about quitting smoking early in the week, particularly on Mondays.
“On New Year’s Day, interest in smoking cessation doubles,” wrote the study’s lead author, John Ayers of San Diego State University. “But New Year’s happens one day a year. Here we’re seeing a spike that happens once a week.”
Besides catching smokers’ attention on Mondays, weekly cues can help people stay on track with their quit attempts. Since it takes an average of seven to 10 quit attempts to succeed, encouraging people to re-quit or recommit to their quit attempt once a week can reduce the overall time it takes to quit for good.
Joanna Cohen, a co-author of the Google study and director of the Johns Hopkins Bloomberg School of Public Health Institute for Global Tobacco Control, believes “campaigns for people to quit may benefit from shifting to weekly cues to increase the number of quit attempts participants make each year.” In other words, quitters can use Monday as a weekly re-set to make another quit attempt if they slip up.
Another advantage to Monday cues is that they tap into what the scientists describe as a collective mindset around quitting. Morgan Johnson, director of programs and research at the Monday Campaigns and another co-author of the Google paper, said that the surge in quitting contemplations on Monday can be used to provide social support for quitters, an important factor in long-term success. “People around the world are starting the week with intentions to quit smoking — if we can connect those people at school, work and communities we can make a regular ‘Monday Quit’ the cultural norm.”