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

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.

As we have previously reported, a drug company, Medicure Pharma, wants sole use of P5P and has petitioned the FDA to ban its use as a supplement entirely. Although Medicure has yet to market a drug made from P5P, it has already petitioned FDA to have the supplement banned now.

This idea of taking what we cannot live without and turning it into a controlled prescription drug is shocking. But this could only be the beginning. We are concerned this new “approved” list of supplements will be used by drug companies to knock out competition from other supplements effortlessly.

For a supplement to get on the grandfathered list, the FDA says it cannot be “chemically altered”—and the definition of that term was another bone of contention at the meeting. Many grandfathered ingredients, because they now go through different (and often safer) manufacturing processes than they did before 1994, could therefore be considered “chemically altered” by the FDA. So either supplement producers would have to revert to pre-DSHEA manufacturing processes, or else they would no longer be on the grandfathered list! Consumers would get the short end of the stick either way, but the FDA doesn’t care.

As we pointed out when the first draft of the guidance was issued, FDA’s stance is so extreme that a ripe apple would be considered “chemically altered” when compared to an unripe apple! Logic would suggest that the production process should not matter if the end ingredient is basically the same.

In all of this, FDA seems to be targeting new, improved, or technologically advanced supplements, presumably because they see them as potential competitors to drugs. If they keep cutting-edge supplements off the market, drug companies can also make big money by selling the older version of the supplement, as Pfizer does with its Centrum multivitamin that we discussed last week.

Here’s another example of why this question of a grandfathered list is so important. Vitamin E is a powerful antioxidant that prevents cell structure damage, boosts the immune system, reduces cholesterol, lowers the risk of developing cancer, thins the blood, helps skin repair itself, and even strengthens your hair. And everyone “knows” that vitamin E was sold prior to 1994. It currently appears on a trade association’s list of grandfathered dietary ingredients. However, this has not yet been vetted or approved by the FDA. If the proper documentation can’t be found, either vitamin E would be off the grandfathered list, or else some forms of E might be listed and others might not. This is important because different forms of the vitamin work very differently. Vitamin E in the form of mixed tocopherols may prevent breast cancer, among other benefits, whereas the common alpha-tocopherol form may not. Some researchers and integrative doctors actually warn against taking alpha-tocopherol alone because it may interfere with the body’s use of the other forms of vitamin E.

Unfortunately, this information has been buried by the media. All of the research on vitamin E that the media has been reporting—and badmouthing—has used alpha-tocopherols instead of mixed tocopherols, as Dr. Jonathan Wright points out in the current issue of his Nutrition and Healing newsletter.

We are pleased that the FDA is including stakeholders at the NDI guidance redraft meetings. We are pleased that consumers were included by inviting us. But there are reasons to be very watchful. We don’t want a grandfathered list that will not only exclude many supplements actually sold before 1994, but will also make it easier to reject all newer supplements. With vigilance and your help, we won’t let that happen.