Navigation Links
Despite FDA Warning, Sports Supplements Still Available Online: Study
Date:12/4/2012

By Denise Mann
HealthDay Reporter

MONDAY, Dec. 3 (HealthDay News) -- DMAA sports supplements have been linked to at least two deaths and the U.S. Food and Drug Administration sent warning letters to 10 manufacturers last spring about a lack of data on their safety, but a new study finds these supplements can still be purchased online.

DMAA (dimethylamylamine) is a pre-workout supplement used by athletes to build muscle. Some research suggests that it may narrow blood vessels, which can elevate blood pressure, and may set the stage for a heart attack. Canada and the U.K have banned DMAA from all supplements.

Now, a small study published online Dec. 3 in the Archives of Internal Medicine reports that all 16 of the products mentioned in the FDA's warning letters are still available through online retailers.

"The FDA has its wings clipped when it comes to dietary supplements because they have to prove harm in order to remove a product from the market," explained study author Philip Gregory, an associate professor of pharmacy practice at Creighton University in Omaha, Neb. "I would imagine that the FDA is collecting data on adverse events and slowly building a case for potentially removing the product."

Efforts by HealthDay to reach the FDA for comment were unsuccessful.

The original FDA warning letters stated that the companies had not provided sufficient data showing the safety of their supplements, and gave the companies 15 business days to respond.

Gregory searched for products singled out by the FDA on Google, and found that all 16 were still available via online retailers and on sale directly from the manufacturers' websites. In addition, 12 of the 16 were available through General Nutrition Centers (GNC), and eight could be purchased via drugstore.com, the study showed.

People are drawn to DMAA supplements because they provide a quick fix, Gregory said. "The product promises them better results and quickly, [and] this is a pretty tempting proposition for someone who is dead set on adding bulk and getting ripped," he said.

"DMAA is a stimulant so the risks revolve around stimulant-related side effects," he added. "We don't have much specific data on case reports describing adverse events, but generally speaking, adverse outcomes have included psychiatric disturbances, cardiovascular risks such as increased blood pressure, palpitations, arrhythmia, heart attack or stroke."

Duffy MacKay, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition in Washington D.C., said that the FDA is likely still in discussions with these companies. CRN is a trade group representing dietary supplement manufacturers and ingredient suppliers.

"The FDA can pull these supplements if they think they pose a risk, so at this point the assumption is that the FDA has not come to that conclusion yet," MacKay said. "The CRN would like to see the FDA take the appropriate regulatory action if warranted."

Unless and until they do, consumers will remain confused, he added. "Consumers should at a minimum know what they are taking and follow the dosing instructions on the product's label, and talk to their health care provider about whether this product is right for them," he said.

GNC issued the following statement regarding DMAA supplements sold in their store:

"All DMAA products sold by GNC are manufactured by third-party vendors. GNC is simply the retailer and, like all retailers, relies upon the contractual representations and warranties made by its vendors that the products are safe and compliant with all applicable laws and regulations," the statement said. "GNC believes the products are compliant with all applicable laws and regulations, and are safe when consumed as directed."

Dr. Pieter Cohen, an internist at Cambridge Health Alliance and an assistant professor of medicine at Harvard Medical School, called for a DMAA ban soon after the FDA sent out the warning letters, and he still thinks the products should be banned.

"Sports supplements produce hundreds of millions of dollars in revenue a year," Cohen said. "This entire class of pre-workout supplements, including DMAA, is very suspect and not a single one is proven to boost athletic performance, and some ingredients have the potential to cause harm. The FDA needs to act and proactively remove the hundreds of products that don't have adequate safety data to support their use."

More information

See the full list of companies that received U.S. Food and Drug Administration warning letters on DMAA.

SOURCES: Philip J. Gregory, Pharm.D., FACN, associate professor, pharmacy practice, Creighton University, Omaha, Neb.; Pieter Cohen, M.D., internist, Cambridge Health Alliance, Boston; Duffy MacKay, N.D., vice president, Scientific and Regulatory Affairs, Council for Responsible Nutrition, Washington, D.C.; Dec. 3, 2012, statement, General Nutrition Centers (GNC); Dec. 3, 2012, Archives of Internal Medicine online


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Many Still Tanning, Despite Dangers, Survey Finds
2. Despite less play, childrens use of imagination increases over 2 decades
3. Despite hardships, black men in urban communities are resilient, MU researcher says
4. Despite clear benefits, heart failure clinics are rarely utilized
5. Seniors Creativity Can Thrive Despite Dementia
6. Undertreatment of common heart condition persists despite rapid adoption of novel therapies
7. Ethnic disparities in breast cancer survival remain despite socioeconomic similarities
8. Pneumonia remains the leading killer of children despite decline in global child deaths
9. UCLA Brain Injury Research Center gets NCAA funding for research on sports concussions
10. Some Sports May Help Protect Mens Bones
11. Fees Lead Some Kids to Skip After-School Sports: Survey
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Despite FDA Warning, Sports Supplements Still Available Online: Study
(Date:4/29/2017)... ... April 29, 2017 , ... TransDark is a set ... one video to the next without having to set a single keyframe in ... to enhance your video production. , TransDark features dynamic transitions that momentarily splits the ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... An April 24th article on ... stunning 180 pounds with the help of a weight loss surgery. The woman, declaring “I ... skin that have been left following her dramatic weight loss. Dr. Feiz & Associates notes ...
(Date:4/28/2017)... , ... April 28, 2017 , ... Beginning in 2017, ... their formulas. This begins with the popular ClearLungs Extra Strength formula. To ensure that ... the formula in the following ways:, , Removal of the ...
(Date:4/28/2017)... ... April 28, 2017 , ... Ushio America ... lamps offer an instant energy-saving solution for F32T8 fluorescent lamps on most instant-start ... ballasts. These 50,000 hour rated lamps utilize the existing electronic ballast, saving labor ...
(Date:4/28/2017)... ... April 28, 2017 , ... From ... College of Urgent Care Medicine will host industry leaders for the annual spring ... help those in the industry adapt to the issues currently affecting urgent care ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... 20, 2017  Cogentix Medical, Inc. (NASDAQ: CGNT), ... the Urology, Uro/Gyn and Gynecology markets with innovative ... has joined the Company as Senior Vice President, ... position, Mr. Keswani will report directly to ... "Our organization is delighted that Ash has joined ...
(Date:4/20/2017)... , April 20, 2017  RXi Pharmaceuticals Corporation ... therapeutics that address significant unmet medical needs, today ... the Company,s consumer product development program, based on ... Society for Investigative Dermatology (SID) 76 th ... and promote the sciences relevant to skin health ...
(Date:4/20/2017)... , April 20, 2017  AbbVie (NYSE: ... 99 percent (n=145/146) of chronic hepatitis C virus ... 5 or 6 and compensated cirrhosis (Child-Pugh A) ... (SVR 12 ) with its investigational, pan-genotypic regimen ... rates were seen following 12 weeks of G/P ...
Breaking Medicine Technology: