FDA Publishes Interim Final Rule On Stanol/Sterol Esters

Claim could have implications for additional functional foods.

By Todd Harrison

The FDA on September 8, 2000 issued an interim final rule authorizing a health claim for plant stanol/sterol esters and a reduced risk of coronary heart disease (CHD)Interim Final Rule 21 C.F.R.. § 101.83 et seq. Unlike past health claims, FDA moved with relative quickness to approve these two claims. It also marked the first time since the enactment of the Food and Drug Administration Modernization Act (FDAMA) of 1997 that FDA issued an interim final rule rather than a proposed health claim. The significance of issuing an interim final rule over a proposed rule is that companies marketing stanol/sterol products that meet the requirements of the interim final rule may immediately start using the health claim on product labels. Of course, companies doing so run somewhat of a risk that the requirements of the final rule will differ from the interim final rule. Thus, it is possible that a food that now qualifies for the claim will not when the final rule is issued and those companies marketing products that do not meet the criteria will be required to cease making the claim for those products until such time the products are reformulated to meet the requirements of the final rule.

The universe of foods that will be eligible to bear the health claim, however, is limited in several important ways. For instance, the universe of foods eligible for the stanol esters health claim is limited to spreads and salad dressing, while the foods eligible for the sterol esters health claim are limited to spreads, salad dressings, snack bars and softgel dietary supplements.

Additionally, the plant stanol/sterol esters must be produced through esterifying the sterol/stanol esters with food grade fatty acids. More specifically, the sterol esters must be esterified by mixing plant sterol esters from edible oils with food-grade fatty acids, while stanol esters must be esterified by mixing plant stanol esters derived from edible oils or byproducts of the kraft paper pulping process with food grade fatty acids. These respective requirements eliminate for now the use of the stanol/sterol health claims on foods that do not esterify the stanol/sterol esters with free fatty acids. Thus, Novartis’ tall oil phytosterol product “Phytrol” is not eligible for the stanol/sterol esters health claim, unless FDA revises its interim rule to permit non-esterified phytosterols to make the claim or until such time that FDA publishes an interim final rule permitting Novartis to make a health claim for its phytosterols. At this time, we are not aware of Novartis filing any such health claim petition with FDA.

The interim final rule requires that certain constituents of the plant sta­nol/sterol esters be present in the final mixture of stanol/sterol esters. The final mixture for the sterol esters must be comprised of at least 80% beta-sitosterol, campesterol and stigmasterol (combined weight). The final mixture for the stanol esters must be comprised of, by combined weight, at least 80% sitostanol and campestanol (combined weight). FDA has requested comments on whether specific ratios or percentages of these particular stanol/sterol esters should be present in the final mixture.

In addition to the composition of the sterol/stanol esters, the food bearing the claim must contain either 1.7 grams of stanol esters or 0.65 grams of sterol esters. The food must also be low in saturated fat (<1 gram) and low in cholesterol (< 60 grams). The food must contain no more than 13 grams of fat per 50 grams of food, unless it is a spread or salad dressing and the label bears the disclosure statement, “See nutrition information for fat content.” FDA, however, has asked for comments on this issue and it is possible, but unlikely, that FDA may require a lower level of fat per 50 grams of food.

As a general rule, a food may not bear a health claim unless it meets the minimum nutrient requirements of 21 C.F.R. § 101.14(e)(6), i.e., the food bearing the health claim must contain at least 10% of the RDI or DRV of vitamin A, vitamin C, calcium, iron, fiber or protein. This requirement does not apply to dietary supplements. To avoid potential problems with this general health claim requirement, the stanol esters petition requested a blanket ex­emp­tion from this requirement, while the sterol esters requirement re­quested an exemption only for salad dressings. FDA rejected the broad exemption requested in the stanol esters petition, but approved an exemption for salad dressing products containing stanol/sterol esters from the minimal nutrient requirements. In so doing, FDA stated that the importance of communicating to the public the cholesterol lowering benefits of the stanol/sterol esters outweighed the importance minimum nutrient content requirement of § 101.14(e)(6). FDA further noted that salad dressing was a good delivery vehicle for the stanol/sterol esters and, unlike spreads and other foods, salad dressings are generally eaten in connection with foods that meet the minimum nutrient requirements, e.g., salads and fresh vegetables.

As with all health claims, there is specific information that must be communicated in the stanol/sterol health claim. (1) The claim must contain language that stanol/sterol esters must be consumed as part of a diet low in saturated fat and cholesterol. (2) The claim must specify the daily intake of sterol esters (1.3 grams per day) or stanol esters (3.4 grams per day) that is associated with a reduced risk of CHD. (3) The claim must also state that the sterol and stanol esters should be consumed in two servings at two different times of the day. FDA developed the following two model health claims for stanol/sterol esters:
Plant Sterol Esters: Foods containing at least 0.65 g per serving of plant sterol esters, eaten twice daily with meals for a daily intake of at least 1.3 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies xx grams of vegetable oil sterol esters.

Plant Stanol Esters: Foods containing at least 1.7 g per serving of plant stanol esters, eaten twice daily with meals for a daily intake of at least 3.4 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies xx grams of vegetable oil stanol esters.

Nutritive Value

In deciding to authorize the interim rule, FDA was obligated by its regulations to consider whether the stan­ol/sterol esters provided aroma, taste or nutritive value to the person consuming the food products containing the stanol/sterol esters. Obviously, the stanol/sterol esters did not provide aroma or taste. Thus, under its regulations, FDA could only authorize the health claim if the stanol/sterol esters had nutritive value. The regulations define “nutritive value” as value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients or providing energy” 21 C.F.R. § 101.14(a)(3). FDA has previously stated that this definition is intended to be flexible and that nutritive value “includes assisting in the efficient functioning of classical nutritional processes and other metabolic processes necessary for the normal maintenance of human existence.” Based on these statements, FDA concluded that stanol/sterol esters provide nutritive value because the cholesterol lowering effect of these esters are achieved through the digestive process.

What FDA did not mention is that the effect is achieved through the sterol/stanol esters’ ability to block the absorption of cholesterol by the body. Indeed, FDA successfully prosecuted a line of cases known as the Starch Blocker cases on the basis that a product that blocks the absorption of carbohydrates is a drug because the act of blocking carbohydrates in the digestive tract is a physiological effect, not a nutritive effect. Thus it appears that FDA has either redefined nutritive value or is simply ignoring it because of the potential health benefits of the stanol/sterol esters. Of course, the issuance of this claim may only be an aberration because the scientific evidence in support of the claim was very strong. Let’s hope not because a loosening of the definition of nutritive value may pave the road for the greater use of struc­ture/function claims for conventional/functional foods.

NW

Todd A. Harrison is a senior associate with the law firm Keller & Heckman, Washington D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on food and dietary supplement adulteration, labeling and advertising issues. He can be reached at Keller & Heckman, 1001 G. St. NW, Suite 500 W, Washington D.C. 20001; 202-434-4244; Fax: 202-434-4646; E-mail: [email protected].