Dietary Supplement Ingredients In Food Among CFSAN 2004 Priorities

Developing "an enforcement strategy for ensuring that dietary supplement ingredients added to conventional foods are lawful" is a program priority that will be addressed by the FDA's Center for Food Safety & Applied Nutrition in FY 2004.

Such a strategy would respond to what a spokesperson for the agency defined as a rising number of supplement ingredients that have been appearing in conventional foods over the past several years.

Initiatives the center will carry over into the next fiscal year were outlined in a report detailing program priority accomplishments in 2003, which was announced by the center Nov. 24.

CFSAN Director Joseph Levitt noted the center met 92%, or 138 out of 150, "A-list" goals set for 2003, exceeding its target of 90%. Included in the report were the 12 remaining priorities that have been carried over for completion in 2004 and where the agency says "substantial progress has been made."

Action was taken by the agency to address the issue of fortified foods in 2001, when roughly 100 letters were sent to supplement manufacturers, reminding them that additives, including botanicals, must be approved as safe before being legally added to foods (¹ (Also see "Botanical Ingredients In Conventional Foods Unapproved, Not GRAS - ONPLDS" - Pink Sheet, 5 Feb, 2001.), p. 3). In order for a supplement ingredient to be added to a conventional food, the manufacturer should use the food additive process or determine that the product is generally recognized as safe, the letter stated.

Four months later, FDA followed up on its action by sending warning letters to three juice manufacturers that were using herbal ingredients in their products (² (Also see "Echinacea Nutrient Content Claims Misbrand Juice Products - FDA" - Pink Sheet, 11 Jun, 2001.), p.4).

Also carried over to 2004 is the planned publication of a final rule for a stanol/sterol esters health claim. The interim final rule on the health claim was issued by the agency in September 2000, but the comment period was reopened in October 2001 after an American Heart Association announcement advising against consumption of sterol/stanol esters by some groups (³ , p. 10).

AHA expressed its concerns to professionals about the substances being consumed by individuals with coronary heart disease, noting that some individuals have unusually high intestinal absorption of plant sterols. The organization suggested further studies to determine the safety of plant sterol intake in those individuals who do not have high cholesterol levels.