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Will FDA’s “Grandfathered” Ingredients Rule Mean No More Real Vitamin E? November 12, 2012

Discussion in 'Other Health News and Research' started by *GG*, Nov 12, 2012.

  1. *GG*

    *GG* senior member

    Concord, NH
    Supplements not on an FDA “approved” list could disappear.

    The NDI guidance interprets the rules for new supplements. After your protests got the first draft scrubbed, work on a second draft continues at FDA. A second meeting between FDA and “stakeholders”—mostly trade groups, with ANH-USA once again the only grassroots consumer group present—took place on October 16.

    As we reported after the first meeting, the New Dietary Ingredients guidelines still pose a major threat. This is because FDA is trying to reaffirm the policies of the original guidance, particularly the elements that could remove huge numbers of supplements from the market.

    Much of the meeting was dedicated to a discussion about how to create a list of “grandfathered” dietary ingredients (supplements). These supplements would have been sold prior to 1994, the year the underlying law, DSHEA, was passed and therefore would not require jumping through further regulatory hoops before being sold. The question was: what evidence would be required to show that a supplement was sold prior to 1994?

    FDA says such a list won’t necessarily be final, and won’t be the only supplements allowed to be sold. But we could easily conceive of that being the outcome if left to the agency. We are also concerned that FDA wants to set the evidentiary bar so high that many supplements which were definitely sold prior to 1994 still won’t pass.

    According to FDA, any of the following is sufficient to prove that a supplement was marketed before DSHEA was passed: an invoice, a bill of lading, a product label, or a catalog, provided it clearly indicates a date. But many companies don’t have this kind of documentation from eighteen years ago! For example, pyridoxamine (a B6 vitamin) was marketed before DSHEA, but no one in the industry has been able to provide the documentation required by FDA. Even signed affidavits from industry members have been inadequate in FDA’s eyes.

    What if a dietary ingredient is, and has always been, in our food? Doesn’t that mean it was “marketed” before 1994? Not to the FDA. The supplement must have been separated out of the food, and sold for its own properties. Human beings have consumed the antioxidant resveratrol for millennia because it’s found naturally in the skin of grapes. But no one in the industry has yet been able to prove that resveratrol was marketed as a separate ingredient or was found on the label of a food or supplement before 1994.

    The problem is a little different with P5P. P5P is the only form of vitamin B6 that the body can use directly. It’s produced naturally in the body: all other forms of B6, whether in food or in supplement form, must be converted to P5P first; without it we die. Most of us don’t get enough B6 in our diet, and some people lack the enzymes needed to convert pyridoxine into P5P.

    There shouldn’t be any problem grandfathering P5P since there is no question that B6 was sold prior to 1994. But the FDA says no. If the form of B6 sold earlier was not P5P, if the label didn’t say P5P, they won’t grandfather it.



    taniaaust1 likes this.
  2. taniaaust1

    taniaaust1 Senior Member

    Sth Australia
    Keep fighting.

    Dont allow to happen what has happened already to so many other countries which got a lot of what was previouslly called supplements removed and no longer available from our natural health stores (eg we lost melatonin and its now only available on a prescription which can be hard to get as doctors dont know much about it and it now costs 10x more then in other countries in which dont have the gov regulations in place. Now we have to order from overseas and places like America often to get things and some not dangerous supplements currently available over the counter in America were even completely banned as they didnt meet gov regulations/rules when they were introduced.

    Regulations like this will end up affecting things far more then you may realise. Increased costs, less supplements available and others more hard or near impossible to get (or banned, not cause they are dangerous but just cause they didnt meet the new rules)

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