According to the proposed rule in the Federal Register, dated December 8, 2010 (Vol. 75, Number 235), the change would provide opportunities for a CHD phytosterol claim for foods including bread and cereal, orange juice, and low-fat dairy foods, as well as allowing non-esterfied phytosterols to make the claim.
In addition, the agency said that a health claim petition submitted by Unilever United States also influenced the action.
In addition to a potential expansion of the foods eligible for the claim, the rule would also redefine phytosterol “to include both phytosterols esterified with certain food-grade fatty acids and, for the conventional foods for which the claim is authorized, nonesterified phytosterols as substances for which the health claim may be made.
“[H]owever, FDA is not proposing that dietary supplements containing only nonesterified phytosterols be eligible for the health claim,” adds the proposal.
Numerous clinical trials in controlled settings have reported that daily consumption of 1.5 to 3 grams of phytosterols/-stanols from foods can reduce total cholesterol levels by eight to 17 per cent, representing a significant reduction in the risk of cardiovascular disease.
“Based on the scientific evidence regarding the relationship of consuming phytosterols with a reduced risk of CHD, FDA tentatively concludes that 2 g of phytosterols per day is the daily dietary intake necessary to achieve the claimed effect,” states FDA.
“Two g per day of plant sterols is the midpoint of the daily intake range of 1 to 3 g used in the majority of intervention studies designed to evaluate their effectiveness in lowering cholesterol.
“FDA has thus tentatively determined that, for purposes of authorizing a health claim relating phytosterol consumption and CHD risk, the daily dietary intake necessary to achieve the claimed effect for phytosterols is 2 g per day. The agency invites comments on this tentative determination.”
The proposed rule is open for comment, written or electronic, by February 22, 2011.
Comparing apples with apples
The FDA review was welcomed by Cara Welch, PhD, scientific & regulatory affairs manager at the Natural Products Association (NPA). Dr Welch told NutraIngredients-USA: “The NPA is very interested in the discussion regarding the expansion of health claims, as consumers are definitely looking for products that can actually provide the health benefits claimed.
“On this particular item we are paying special attention to the appropriateness of expanding the claims to products that have not traditionally had such claims. With that stated one of the critical factors will be the comparison of trials, where matrix effect has to be considered and so the experts can correctly compare apples to apples, not apples to oranges, when considering the food product that contains phytosterols,” she added.