While the FDA has yet to respond to the petitions, its decision – released last Thursday - to re-open the comment period* on the proposals has raised hopes that it is at least listening to stakeholders’ concerns.
No claims for supplements containing free phytosterols
The proposed rule - published in December 2010 - would allow conventional foods containing free (non-esterified) as well as esterified phytosterols to make coronary heart disease (CHD) risk reduction claims and broaden the range of foods allowed to make such claims.
But it would also increase dosages required for claims from 0.4g to 0.5g per serving and prevent firms selling supplements containing free phytosterols from making heart health claims, something critics argue is not based on sound science and could cause significant damage.
Botanical Laboratories: FDA rule will doom our new product
Cargill was first to respond, firing off a petition in January calling for the FDA to hold fire until a final ruling is published. But since then, three more firms have come forward to make the same request.
One – Washington-based supplement maker Botanical Laboratories – claimed the FDA had effectively scuppered its launch plans for a new supplement.
The firm, which makes supplements under the Wellesse brand, said: “Prior to the amendment … Botanical Laboratories was poised to introduce a heart health liquid dietary supplement featuring sufficient free phytosterols per 2-tablespoon serving to meet the requirements of the 2003 enforcement discretion letters.”
If the FDA rejected its petition, it would suffer “irreparable injury”, it claimed.
”Botanical Laboratories’ product development work would need to be redone to determine whether esterified phytosterols can be formulated into a shelf stable palatable liquid dietary supplement.
“Esterified phytosterols are more expensive than the free form… a finished liquid product containing that form may be cost prohibitive and not commercially viable. Thus, failure to grant a stay will likely doom this proposed product.”
FDA should ‘abandon its blanket approach’
It also challenged the FDA’s view that evidence supporting the cholesterol-lowering abilities of supplements containing free phytosterols was “limited and inconsistent”.
It added: “It is unfair to conclude that all forms of dietary supplements containing free phytosterols should be barred from using the health claim… Substantial evidence exists that free phytosterols are effective and that the form of the dietary supplement matters.”
The FDA should “abandon its blanket approach and instead adopt an approach narrowly tailored to address the concern that certain dietary supplement formulations may not effectively reduce cholesterol”, argued the firm.
“This petition for stay seeks to allow the claim for nonesterified emulsified phytosterols in aqueous liquid forms, where they would be easily dispersed.”
Free phytosterol dietary supplement market will ‘evaporate swiftly’
Pharmavite – which makes the CholestOff dietary supplement containing a blend of free phytosterols and phytostanols – has also urged the FDA to think again.
Dietary supplements containing free phytosterols “that have been shown, through an adequate and well-controlled clinical trial, to reduce LDL and total cholesterol”, should be permitted to make claims, it argues.
Finally Pharmachem - which manufacturers Reducol: a free phytosterol ingredient in a granulated form that can be compressed into tablets - claimed consumers would suffer were the rules changed.
Pharmachem’s major customer for Reducol supplied a “considerable percentage of the US market for dietary supplements containing free phytosterols”, it added.
“Many consumers will have to change to supplements containing esterified plant sterol esters, which are in a softgel cap form carrying a higher retail price. This could very well put dietary supplements with phytosterols out of their reach.
“Pharmachem and its customers will be irreparably injured by the loss of the free phytosterol dietary supplement market, which will evaporate swiftly if the stay is not granted.”
FDA: We could change our minds…
*In a summary published in the Federal Register last Thursday, the FDA said it would give stakeholders until October 25, 2011 to respond to its December 2010 proposal.
It added: “The reopening of the comment period may result in the submission of additional information that may cause the Agency to reconsider its proposed amendments to the phytosterols and risk of coronary heart disease health claim.”