CRN scientific & regulatory affairs vice president Duffy MacKay was speaking to NutraIngredients-USA after the FDA re-opened the comment period on a proposal it published last December that would ban firms making supplements containing free (no-esterified) phytosterols from making claims.
The fact that the FDA was now inviting further comment before coming up with a final ruling on the criteria for making phytosterol/heart health claims was good news, said Mackay.
The proposal in question, which will significantly reduce the number of supplements permitted to make coronary heart disease (CHD) reduction claims, was becoming increasingly difficult to justify on scientific grounds, he added.
The issue is about dispersibility
“The issue is about dispersibility. The FDA referred to some negative studies on this issues, but several companies have now presented data that proves their supplements with free phytosterols are effective at lowering cholesterol, and that what matters is getting the formulation right.”
For example, some free phytosterol powdered supplements designed to be added to foods or drinks before consumption overcame dissolution and distribution limitations,while tablet and capsule formulations of free phytosterols that disintegrated efficiently had also been shown to be effective at lowering serum cholesterol, he claimed.
Enforcement activity, therefore, should be conducted on a case-by-case basis, he said, with firms able to prove the efficacy of their free phytosterol formulations permitted to make CHD risk reduction claims.
If the FDA ultimately proved inflexible on this issue, firms currently making supplements with free phytosterols would either have to remove health claims from their packs or reformulate their products using esterified phytosterols, which meant more expense and more tablets, he said.
“What you used to be able to get in three supplements would now take six.”
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.”
Click here to read more about firms (Cargill, Pharmachem, Pharmavite and Botanical Laboratories), that have challenged the FDA’s proposal.