Articles by Natural Health Author Barbara Minton
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New FDA Guidance May Put Your Supplements in Jeopardy - Part 2
by Barbara Minton
(The Best Years in Life) This is the concluding article in an important two-part series. In part 1 of this two-part series, we discussed how new FDA guidelines may result in us losing our access to the dietary supplements we have come to depend on for our health. We also explained how, unless we take action quickly, in a few years there may be only a handful of supplement companies left, each owned or controlled by Big Pharma, and each charging drug-like prices for supplements.
New guidance shows nothing has changed at the FDA
The revision finally arrived in August. Both National Health Federation (NHF) and the Alliance for Natural Health USA (ANF-USA) have said that while there is some small improvement, the biggest problems remain.
For Scott Tips, president of NHF, this guidance is the same old story. “The agency, under the guise of protecting us, is really just protecting its funder, the drug industry, and is throttling any chance of innovation and improvement in supplements. This is so corrupt that it is hard to understand how Congress can continue to turn a blind eye to it, but of course Big Pharma funds political campaigns as well.”
ANH-USA weighed in by writing “The guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA describes how to determine what kind of safety studies to submit with an NDI notification. Note that safety studies in the past have been required of drugs, not supplements. In addition the agency states that additional safety studies may be needed if the target population changes.” This can mean the supplement becomes targeted at children or the elderly.
“Are other drugs – even dangerous anti-psychotics, antidepressants, and stimulants – subject to similar requirements when they are used on children? The answer is a resounding NO. In the FDA’s own words, ‘Most drugs prescribed for children have not been tested in children.’ The same is true for use with elderly people”, continues ANH-USA.
Under current protocol, if an ingredient is being studied for use as part of a new drug, that ingredient can no longer be produced or included in a supplement if a NDI has not previously been accepted. This has already happened with a valuable form of Vitamin B-6. What will disappear next?
Continued confusion about what has been grandfathered in also remains, leaving leeway for a drug company to claim a supplement that has been around for decades has been altered to the point where it can be claimed as a drug.
The FDA has also held on to its position that most synthetic botanical ingredients are not dietary ingredients. This places such supplements as vinpocetine, a particularly effective supplement for a healthy brain, in jeopardy of being grabbed off the shelves by the zealous agency.
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In addition, the new guidance is adding to the group of substances requiring NDIs by loosening its definition of “chemically altered”. If a pre-DSHEA ingredient has not been chemically altered, it requires no NDI notice. This is more to stifle innovation and manufacturing, and it intentionally ignores that new and more effective ways of producing supplements have come along in the last two decades.
ANH-USA has speculated that probiotics, the friendly bacteria that keep the immune system strong, may be the next on the chopping block, citing that Big Pharma is highly interested in producing its own versions of the product, but at what price!
“This is pure nonsense,” writes ANH-USA. “Why would the FDA do this? Clearly these are the actions of an agency looking to restrict the supplement market and remove as many products as possible in as many ways as possible – even though it openly defies the intent of Congress in passing DSHEA, which was meant to expand consumer access to dietary supplement.”
For ANH-USA it being clear that the FDA is unable to provide credible oversight of the supplement industry. They are calling for another regulator to be appointed.
Tips concurs. “The FDA has yet to be either humbled by the judiciary or sent a clear directive by Congress. There is nothing in the last 22 years of FDA conduct or in the FDA’s recent regulatory actions that provides us with the least hint that it will act in good faith.”
If you agree with what these natural health authorities have said, be sure to take action here.
Silver's Fight for Health Freedom
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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