Alert: FDA Attempting to Halt Creation of New Supplements
We need all hands on deck. The Alliance for Natural Health USA just broke out its highest level action alert. This may be the worst attack on natural health supplements since the early 1990s. Time will tell as more information becomes available.
In 2011, the FDA created a troublesome revision of how the supplement industry could comply with the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA had successfully replaced an Act that would have blocked consumer rights in a major way and tightly restrict natural supplements. Essentially, DSHEA is why we currently enjoy consumer access to natural health products of all kinds.
According to natural health advocacy groups, the FDA’s 2011 revisions were a thinly veiled reversal of the consumer rights that were so hard to keep to begin with. In other words, it was an attempt to block the natural health industry and clamp down on consumer access once again. After some outcry, the FDA went back to revise, and now, this is the draft the ANH-USA has been waiting for.
Unfortunately, aside from a couple “crumbs” of improvement, the draft appears to reverse the relative freedom of consumer and industry under DSHEA. Furthermore, it already appears to be incredibly confusing.
Over the last few years, one of the biggest issues facing the supplement industry has been the confusion over how to comply with the new dietary ingredient (NDI) provisions contained in the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA), the main law governing supplements. For the layman, “new dietary ingredient” is usually just government jargon for “new supplement.”
Under DSHEA, any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product.
The 2011 draft put forth the FDA’s approach on how companies should comply with DSHEA’s NDI requirements, i.e., how and when a NDI notification should be submitted, what info was required, what is an NDI, among other things.
ANH-USA expresses some startling information on the new draft below. Essentially, the requirements for new supplements, even within the same company are so rigorous as to break them. Furthermore, it appears the companies can be easily run out by Big Pharma. Does that mean we can say good-bye to Amazon orders or a skip to the friendly neighborhood health food store?
It is a little better in some respects, but the biggest problems remain. It represents a dire threat to the supplement industry and, by extension, consumer access to supplements.
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.
Are other drugs—even dangerous antipsychotics, 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.
Remember that an IND refers to a new drug, while an NDI refers to a new supplement. Under current law, if an IND application is filed for an ingredient—that is, 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 to pyridoxamine, a form of vitamin B6, even though in the end it resulted in this valuable form of natural B6 being no longer available either as supplement or drug.
Apparently the FDA couldn’t care less that this form of natural B6 is no longer available in any form. Indeed it has been considering a petition to ban the only remaining natural form of B6, the most important form of all, because all B6, synthetic or natural, must be converted to it in order for our bodies to use it.
The 2011 draft guidance threatened to cripple — if not eliminate — the supplement industry. An economic analysis at the time from an Emory University professor estimated that the FDA’s outrageous interpretation of the DSHEA-mandated NDI notification language would have meant: the elimination of tens of thousands of supplements from the market; an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and the loss of between 55,270 and 104,475 jobs in the supplement industry.
At this point, ANH-USA says that any “enterprising drug company [can] corner the market on a whole list of ingredients to keep them out of the hands of supplement formulators forever.”
The language apparently stifles innovations and bypasses the fact that it’s been 22 years and there have been numerous manufacturing innovations since DSHEA. The ANH feels that the true aim is to destroy the supplement industry and it certainly looks that way.
Despite the fact that probiotics like acidophilus are scientifically proven to treat at least 18 conditions – probiotics are on the chopping block! The FDA has cited “risks.” Coincidentally, now that the importance of the gut microbiome for healing is out of the scientific bag – after a nation of people have destroyed their guts with doctor-prescribed antibiotics and fast food – the FDA wants to crack down on them. Of course it does.
ANH-USA points out this coincidence: that Big Pharma has developed its own probiotics which could lead to subjection to costly prescription versions. Perhaps only the prescription kind. In that case, maybe none of this was “coincidental” at all.
If you want to know more and stay afloat on this issue, you should head over to http://www.anh-usa.org/ because it’s already clear that the FDA is mucking up the text and confusing people on what the supplement industry can or cannot do. As AND-USA says – it is clear that the FDA cannot credibly oversee the supplement industry – the bias toward Big Pharma is unparalleled – another body must provide oversight. Take action below or at ANH-USA’s website.
*It is important to try and personalize your response to your Senators, Representatives and the FDA* You can see my Facebook post as an example. You may wish to post a similar status and share with your friends – it is that important.
Action Alert! Write to Congress and the FDA to protest this revised guidance that threatens our access to supplements. Please send your message immediately.
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