Time is running out for cardio claims on free phytosterol supplements

Under a controversial Food and Drug Administration (FDA) proposal published in December 2010, supplement makers will have to remove these claims - or reformulate products with esterified phytosterols - by February 21.

While some stakeholders had hoped the FDA’s decision to re-open comments on the proposal last year suggested a change of heart, it has not yet given the trade any indication that it will budge, with less than two weeks to go before the rule-change kicks in.

Claims should be permitted if firms have supporting evidence​

The issue is a significant one for the trade, given that the majority of phytosterol supplements on the market contain phytosterols in their free form.

Several firms ​have petitioned the FDA to change its stance and challenged its argument that evidence supporting the cholesterol-lowering abilities of supplements containing free phytosterols is ‘limited and inconsistent’.

They also point out that esterified phytosterols are more expensive and that switching would mean consumers would have to take more capsules a day to get an efficacious dose.

Pfizer: Centrum Cardio supplements are proven to lower cholesterol​

In a comment filed with the FDA last October, ​Pfizer urged the agency to expand the cardio health claim to supplements using non-esterified phytosterols in tablet form provided certain criteria are met.

It added: ​“Pfizer asserts that dietary supplements containing non-esterified phytosterols that meet the following ‘Nature of the Food Eligible to Bear the Claim’-type criteria, have comparable efficacy with esterified phytosterols in a food matrix and therefore should be eligible to make the health claim.”​

The criteria include:

1) Meeting USP’s disintegration method for multivitamins

2) Demonstrating the non-esterified phytosterols efficiently disperse from the tablet matrix and demonstrate significant efficacy in blocking cholesterol uptake into the mixed micelles using a TNO TIM-1 or comparable model.

In the meantime, the firm has changed the packaging of its heart-health supplements to remove the FDA-backed claim.

CRN: People are getting nervous​

However, time is now running out for firms that haven't yet acted to comply with the new rule, said the Council for Responsible Nutrition (CRN), which accused the FDA of putting firms in an “untenable​” position​ in a submission to the FDA on the proposed rule last year.

Speaking to NutraIngredients-USA yesterday, CRN vice president, scientific and regulatory affairs, Duffy Mackay, said: “People are getting nervous now. This is a big deal. There are some well-established big name products out there with mainstream distribution ​[that contain free phytosterols and make the FDA-approved health claim].”

Meanwhile, there was the added worry that ​firms might spend a fortune changing labels or formulations to comply with the Dec 2010 proposal, only to have to change them again if the FDA takes a different stance when it publishes its final rule at some unspecified point in the future, he said.

Today most phytosterol supplements contain the ‘free’ form​

Although an Interim Final Rule published in 2000 only allowed products containing esterified phytosterols to make cardiovascular health claims, the FDA issued an enforcement discretion letter in 2003 that authorized such claims on supplements containing non-esterified or ‘free’ phytosterols, provided they met the conditions of use.

The CRN has called for the FDA to continue to exercise enforcement discretion in accordance with the 2003 letter until the effective date of any final rule.