Stop the FDA From Outlawing New Supplements
Newly Proposed Mandate Will Raise Prices, Limit Products, and Strangle Innovation in Nutritional Supplements Industry
FT. LAUDERDALE, Fla., Sept. 8, 2011 /PRNewswire/ -- Life Extension, a pioneer in the latest anti-aging research and integrative health therapies, that offers superior quality, research-backed dietary supplements, is alerting consumers to the draconian FDA proposals aimed at dietary supplements introduced after October 15, 1994. Life Extension argues that these rules will raise supplement prices for consumers, reduce allowable levels of key nutrients, totally remove a wide range of existing supplements from the marketplace, and severely limit innovation in the industry. As a result, Life Extension urges consumers to contact government representatives and protest these egregious policies.
Excessive Safety Regulations
According to the proposed regulations, the FDA believes that "new dietary supplements" must be regulated similarly to synthetic food preservatives, which includes the implementation of exaggerated safety thresholds. The proposed safety thresholds are in excess of those required by pharmaceutical drugs, despite evidence demonstrating that supplements are far safer than drugs. According to the most recent report of the American Association of Poison Control Centers (AAPCC), medications remained the leading cause of poisoning deaths in 2009. The report, based on yearly data from calls to U.S. poison centers, found that sedatives/hypnotics/ antipsychotics, cardiovascular drugs, opioids and acetaminophen combinations were most frequently associated with poison-related deaths. Only 41 adverse events and 1 death were reported for the entire spectrum of dietary supplements, including botanicals, amino acids, and vitamins. In contrast, over 7,000 major adverse events were reported for pharmaceutical drugs, include a total of 496 deaths.
Furthermore, the FDA's proposed guidelines are so flawed that even nutrients shown to be completely safe in hundreds of clinical human studies would fail to accommodate the new, unreasonable safety margins. As an example, each manufacturer of fish oils would have to conduct a one year study where animals would have to consume the human equivalent of 240,000 milligrams/day of fish oil. Note the typical dose of EPA/DHA people take daily is 2,400 mg – 100 times less than what the FDA proposes must be tested. Since these are not patented drugs, no supplement maker will be able to afford these "safety" studies which will translate into higher prices for consumers.
Who Benefits from the Proposed Guidelines? Not Consumers.
The pharmaceutical industry, not consumers, will benefit from this mandate. If the new rules are enacted, the price of supplements will surge upwards while removing many effective ones from the marketplace altogether. That means more aging people will have to rely on side-effect laden prescription drugs to treat the diseases they will contract because they will be denied access to preventative, health-promoting nutrients.
What Consumers Can Do
Concerned consumers can take the following steps to make their voices heard against the proposed FDA guidelines:
- Sign and send a petition letter to the FDA Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements.
- Call the FDA at 1-888-723-3366 and read the petition to personnel at the Office of Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements.
- Send a Freedom of Information Act (FOIA) Request to find out what pharmaceutical interests are behind these absurd proposals that will cause the cost of what supplements remain on the free market to skyrocket in price.
- Send a letter to their Representative and two Senators demanding the FDA immediately withdraw their oppressive proposed guidelines pending rational discussions with those who depend on dietary supplements to protect their health and livelihood.
- Send a letter to the President's Office of Management and Budget as the FDA's proposed guidelines on new dietary ingredients directly conflicts with an Executive Order issued July 11, 2011 that orders the FDA to streamline and repeal burdensome regulations that interfere with job creation, economic growth, and innovation.
About Life Extension®
For more than 30 years, Life Extension® has been a pioneer in funding and reporting the latest anti-aging research and integrative health therapies while offering superior-quality dietary supplements to consumers. A trailblazer in the $26 billion U.S. dietary supplements industry, Life Extension's core mission is to extend the healthy human lifespan using an integrative approach and funding cutting edge scientific research. For more information, visit www.lef.org, www.Twitter.com/LifeExtension, www.Facebook.com/LifeExtension and www.YouTube.com/LifeExtension.
Rey Searles, Director of Marketing
SOURCE Life Extension
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