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
Suggested text is below.
-- 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.
Copyright PRNewswire 2011
Suggested Letter Text from Life Extension:
A new book Pharmocracy (Praktikos Books, September 2011) reveals how congress can amend the law to resolve todayís health care cost crisis and spare Medicare from insolvency.
As a first step, I urge you to introduce legislation that will enable GMP-certified manufacturing facilities to produce generic prescription drugs that do not have to undergo the excessive regulatory hurdles that force consumers to pay egregiously inflated prices for generic drugs.
The cost of prescription drugs is a significant contributing factor to todayís health care cost crisis, a problem that threatens to bankrupt consumers and this nationís medical system. Passage of this common-sense legislation will quickly slash the cost of generic drugs so low that consumers could obtain them for less than their current co-pays. This will save governmental and private health insurance programs, and ultimately consumers, enormous amounts of money.
Please donít be influenced by pessimistic alarmists who claim that less regulation automatically means more dangerous drugs. These kinds of scare tactics have been used for decades to force Americans to pay outlandish prices for their medications. And please donít be influenced by pharmaceutical lobbyists who will do and say anything to protect their virtual monopoly over generic drug manufacturing.
The bottom line is that we as a nation can no longer afford to be bound by todayís inefficient regulatory system that artificially inflates the cost of our prescription medications. The money is no longer there to support this bureaucratic morass, and you know that as well as anyone.
Kindly let me know how you plan to implement legislation that will help save this country from horrifically overpriced prescription drugs.