Industry is calling on the FDA to extend the compliance period to proposed changes the agency is making for a phytosterol-based coronary heart disease (CHD)-lowering health claim that will broaden it beyond esterified forms to include free sterol and stanol forms, but may threaten product ranges.
The proposed changes, prompted by a Unilever US application to expand the claim to allow free esters to be used in bread and cereal, orange juice, and low-fat dairy foods, would appear to benefit the broader industry, but there are concerns about other provisions such as a requirement that foods must bear 500mg of phytosterols to be eligible for the claim. The existing level is 400mg.
Esterified and free sterol form supplier, Cargill, has expressed such concerns for both foods and supplements, along with groups such as the Council for Responsible Nutrition (CRN), and they have submitted them to the FDA in the comment period that remains open until February 22, 2011.
Cargill called for the FDA to exercise enforcement discretion – especially for ingredients that may not have GRAS approval or had approval but at less than 500mg per serving – as it has done since 2003, or the company and other sterol/stanol players would face, “irreparable injury”.
Cargill said if the FDA began enforcement based on the proposed rule, many products would be forced to remove products bearing, “health claims that were permissible under the 2003 letter.”
“Even if Cargill submitted GRAS notification today for all of its phytosterol ingredients for use in conventional foods at the newly proposed level, FDA could not reasonably review those notifications…and provide ‘No Questions’ responses by February 21,” Cargill wrote in its January 7, 2011, letter to the FDA via the Covington and Burling legal firm.
It said technological challenges made it near-impossible to meet the new criteria and estimated it would take between 16 and 34 months for such changes to occur.
The agro giant echoed CRN’s concerns that almost all phytosterol dietary supplements would also be barred from making claims. The trade group at Christmas called for an 18 month compliance extension to allow companies to either reformulate or alter label claims.
The proposed rule change suggests 2g of phytosterols must be consumed per day, the same level as that approved in the European Union for a cholesterol-lowering claim, and which the FDA said represented a median between the 1-3g levels found in most intervention studies.
Cargill’s submitted comments can be found here.
The FDA’s proposed rule can be found here.