Articles by Natural Health Author Barbara Minton
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New FDA Guidance May Put Your Supplements in Jeopardy - Part 1
by Barbara Minton
(The Best Years in Life) Is it possible that we as a people may lose access to the dietary supplements we have come to depend on for our health? Could it be that if we don’t take action quickly, in a few years there will be only a handful of supplement companies left, each owned or controlled by Big Pharma, and each charging drug-like prices for supplements?
Dietary supplements have become a big business, with sales totaling almost $37 billion in 2014 alone. As a result, the pharmaceutical industry is using its toady, the FDA, to launch a war on supplements and their makers, so that it can eliminate the competition posed by the supplement industry. Of course this is being done under the guise of keeping us safe – the push being that supplements are currently not regulated as drugs are, so that means they are unsafe.
Before buying into this specious logic, remember that properly prescribed drugs cause about 128,000 deaths each year, making them the most dangerous substances on the market today. But there are about 60 billion doses of dietary supplements taken each year, and there has not been one single death caused by using them.
Several media outlets have gotten on the bandwagon to stop supplements too. One of their biggest offensives came in November, 2015, when CBS News broadcasted a “report” stating that what was inside a supplement often did not live up to what was printed on the label. But shortly after that airing, the supplement makers were vindicated by independent testing, and CBS was left with egg on its face.
Shortly after, an episode of PBS’s Frontline slammed supplements again, saying the taking of vitamins and other supplements could be dangerous. But public outcry following its broadcast was so strong that an appointed official, Michel Getler, was brought in to determine whether the complaints were valid. He found no evidence that taking supplements could lead to a healthcare calamity, as the show had predicted.
Now Consumer Reports has gotten into the fray, repeating the mantra that because supplements are not regulated like drugs are, they are putting users at risk. Leading the charge this time was Dr. Paul Offit, known by almost everyone in the natural health world for his expediency, and the way he makes it up as he goes. But such propaganda and fear mongering is to be expected. It’s a sign of the times.
The truth is that supplements have an enviable record of safety and integrity seldom seen in a product. Regulating them in the same manner in which drugs are regulated would achieve nothing but higher prices for them. Supplements are already as safe as they can be. However, this is not true of pharmaceutical drugs, and that is where the effort to create positive change should be.
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When it comes to understanding the peril dietary supplements and the companies that make them are facing, let history be your guide
The first attempts at regulation of dietary supplements came in the 1920’s, when the FDA seized cod liver oil being promoted for its Vitamin A and D content. This action was justified by a wrong headed idea of the FDA’s that supplements were unnecessary for people who eat properly - an idea that has persists to this day, even though today’s food supply is largely bereft of nutrients.
During the 1950’s the FDA launched an intensive enforcement campaign, bringing hundreds of seizures, injunctions and criminal actions against what it decided were misbranded dietary supplements. But these attempts failed to put much of a dent in the public’s fervor for supplements.
Next the FDA proposed new regulations aimed at limiting specific nutrients and their levels in supplements. But in 1974, an appeals court overruled parts of the regulations then in place, and the remainder was stayed. Sen. William Proxmire (D-Wis) led the enactment of the Vitamin-Mineral Amendments of 1974, which eroded the ability of the FDA to regulate supplements.
Then came the Nutrition Labeling and Education Act of 1990. This gave the FDA authority to approve disease prevention claims for dietary supplements, as well as for all foods. In 1992, the FDA published its Task Force Report on Dietary Supplements, which included a statement that said dietary supplements represent a “disincentive for patented drug research”. About that time, the Tacoma Clinic of Dr. Jonathan Wright was raided a gun point. All this emboldened the FDA Commissioner at the time, David Kessler, who saw a way to regain ground in favor of regulation. Though he was advised to go slowly by his peers, Kessler announced in 1993 that the FDA would not approve any claims for dietary supplements, even if the ingredient was already approved for food. In addition, he set out to attack dietary supplement ingredients on the basis that they were illegal food additives that must be removed from the market. Needless to say, his dictates were a very bad decision for everyone.
What followed was a grassroots effort regarded as one of the most successful political movements in American history. All the stops were pulled out against Keller’s policies, and every health food store owner and irate citizen called for congress to stop the FDA from implementing Kessler’s dictates. During the election of 1994, people insisted the FDA must be stopped from taking away their right to consume dietary supplements. Just before the election, Rep. Henry Waxman, (D-Calif) said he was prepared to negotiate a dietary supplement law. A final bill was quickly put together, and in October, 1994, the Dietary Supplement Health and Education Act (DSHEA) was born.
DSHEA drew a line in the sand. Under its legislation, dietary supplements introduced into the U.S. before 1994 were automatically grandfathered in. Supplements coming to market after that date were considered “new”, and fair game for the FDA. Such a supplement is now referred to as a new dietary ingredient (NDI). What to do about NDIs has been a great source of confusion since the beginning of DSHEA.
In 2011, 17 years after DSHEA, the FDA finally released draft guidance for compliance to NDI requirements. This left supplement makers dumbfounded because it practically eliminated their industry.
At the time, an Emory University professor said this ridiculous interpretation of DSHEA’s NDIs would mean
After the adverse reaction that followed, Rep. Peter Roskam (R-IL) signaled that the intent of DSHEA had been reversed by the FDA. While it was meant to expand consumer access to supplements, the FDA’s guidance was restricting it almost out of existence. The strong advocates of free access to dietary supplements urged the FDA to think again, and it agreed to do so, an action that should have aroused suspicion at the time.
New FDA Guidance May Put Your
Supplements in Jeopardy - Part 2
About the author:
Barbara is a school psychologist and the author of Dividend Capture, a book on personal finance. She is a breast cancer survivor using bioidentical hormone therapy, and a passionate advocate of natural health with hundreds of articles on many aspects of health and wellness. She is the editor and publisher of AlignLife's Health Secrets Newsletter.
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