According to the proposed rule (Federal Register, 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.
However, in a letter to FDA, Douglas MacKay, ND, CRN’s VP of scientific and regulatory affairs, states that the Council has concernsthat the proposed change would “exclude all dietary supplement products that contain free phytosterols”.
“CRN has concerns that the Agency’s proposed action to exclude all dietary supplement products that contain free phytosterols from bearing the approved health claim does not reflect full consideration of the impact of all delivery matrices on the efficacy of dietary supplements containing free phytosterols,” wrote Dr MacKay.
“In addition to tablets, softgels and capsules, dietary supplements can be formulated as dry powders that are intended to be blended into a food or beverage prior to consumption,” added Dr MacKay. “A free phytosterol powdered dietary supplement that is reconstituted into a food or liquid beverage will overcome dissolution and distribution limitations that may occur with the tablet or capsule form of free phytosterols.”
Disintegration time of dietary supplements is an aspect that FDA should consider, said Dr MacKay.
“A closer look at disintegration time and efficacy data reveals that disintegration of the specific dietary supplement delivery matrix is an important variable that needs consideration when evaluating the effect of free phytosterols taken as dietary supplements.
“It is noteworthy that disintegration time has been an important variable for other FDA approved nutrition‐related health claims,” he added.
A precedent has already been set by FDA using the United States Pharmacopeia (USP) standards, said the CRN man, with USP disintegration and dissolution standards applicable to dietary supplements bearing the FDA-approved health claim for folate and neural tube defects, “except that if there are no applicable USP standards, the folate in the dietary supplement shall be shown to be bioavailable under the conditions of use stated on the product label”.
“Therefore, the FDA has set a precedent for the consideration of disintegration and dissolution standards as specific requirements for health claim use.
“In summary, CRN believes that the phytosterol health claim should be allowed for powdered dietary supplements containing free phytosterols and for dietary supplements in other delivery matrices that meet or exceed USP disintegration time,” concluded MacKay.
The proposed change initially outlined a compliance deadline of February 22, 2011, but industry was quick to note that this was too soon to enable the relabeling and reformulating of products.
Indeed, agro-giant Cargill voiced concerns last year that the proposed change would cause “irreparable injury” if the compliance date was kept as February 2011. FDA has since extended this until February 21, 2012.