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ProCaps Laboratories: FDA is wrong about free phytosterols

By Elaine Watson , 08-Nov-2011

Supplement maker ProCaps Laboratories has weighed into the row over whether dietary supplements containing ‘free’ non-esterified phytosterols should be allowed to make coronary heart disease risk reduction claims.

The firm has joined a growing number of companies submitting comments to the FDA urging it to rethink a controversial December 2010 proposal that would ban such claims on supplements containing non-esterified sterols by February 2012.

We urge the FDA to reconsider

In a submission to the FDA following the re-opening of the comment period on the Dec 2010 proposal, ProCaps’ medical director Joe Goldstrich said: “We have been offering our encapsulated non-esterified phytosterol product for over seven years, and it has been very well received by our customers.

“We have over 200 reviews with an average rating of 4.3/5. We would urge the FDA to continue to allow the coronary heart disease risk reduction health claim for encapsulated non-esterified, as well as esterified phytosterol dietary supplements.

“The free phytosterol, the form that § 101.83 [the FDA’s December 2010 proposal] seeks to prohibit, is the active form, which the ester must be hydrolyzed into to become active. As stated in Dr. Grundy’s paper almost 30 years ago,'only when the phytosterol is present as the free sterol can beta-sitosterol co-precipitate with cholesterol, with the consequent decrease in cholesterol absorption'."

FDA should evaluate recent research before changing the rules

Goldstrich also challenged the FDA’s interpretation of three clinical studies in the controversial Dec 2010 proposal.

We believe that the references cited [by the FDA] do not support [the FDA’s claims about the] lack of efficacy of non-esterified phytosterols.”

The FDA had also failed to take more recent research into account, he claimed: “As others commenting on this revision have pointed out, there has been significant research published in the past five years that the FDA has not included in its evaluation.

“We would urge that this more recent research be evaluated prior to any changes to the current claim.”

Time is running out

The Council for Responsible Nutrition (CRN) has also urged the FDA to rethink its Dec 2010 proposal to discontinue its policy of enforcement discretion on phytosterol health claims, which has allowed claims on supplements containing free phytosterols since 2003.

The proposal came as rude shock to the trade given that the FDA’s 2003 enforcement discretion letter “unequivocally stated that enforcement discretion would remain in effect until issuance of a final rule”, said CRN vice president, scientific and regulatory affairs, Duffy MacKay.

“[This] has created an untenable situation for the dietary supplement industry.”

As the official date for enforcement discretion to end is February 2012, supplement makers now have less than three months to change their labels and formulations to comply with the Dec 2010 proposal, said MacKay.

To add insult to injury, they then faced the prospect of the FDA’s changing the goalposts again when it published its final rule on phytosterols and health claims at some unspecified point in the future, he added.

The CRN is calling for the FDA to continue to exercise enforcement discretion in accordance with the 2003 letters until the effective date of the final rule, “or, at a minimum, until the next uniform compliance date for food of January 1, 2014”.

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