On January 23, 2007, FDA made an announcement about the use of the term “gluten-free.” The FDA proposed a new definition for the term and provided guidelines for its voluntary use in labeling foods. The proposal was designed to make it easier to identify packaged foods that are safe for persons with celiac disease (also known as celiac sprue or gluten-sensitive enteropathy) to eat. The FDA’s proposal is a result of the Food Allergen Labeling and Consumer Protection Act of 2004, which became law on August 2, 2004. That law required the Secretary of Health and Human Services to propose (and later make final) a rule that defines term “gluten-free” and permits its use in food labeling. Prior to this proposed rule, the industry used the term “gluten-free,” and FDA exercised its enforcement discretion by not enforcing against its use.
Comments in response to the proposed rule must be submitted to FDA on or before April 23, 2007.
Guidance for Industry Regarding Food Labeling
On January 30, 2007, FDA issued a general guidance letter reminding food manufacturers of the claims permitted to appear on the labels of conventional foods and how such claims are regulated. FDA indicated that the letter was necessary because of inappropriate claims being made in the industry. A copy of the letter can be found at http://www.cfsan.fda.gov/~dms/flguid.html.
Proposed Rule: Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
On February 6, 2007, FDA announced a proposed rule to amend the health claim characterizing the relationship between soluble fiber from certain foods and risk of coronary heart disease (CHD). The amendment proposes to exempt certain foods from nutrient content requirements that must be met in order to be labeled as “low fat.” Once finalized, the exemption would apply to foods that exceed current requirements because of fat content derived from whole oat sources. FDA published the proposed rule in response to a petition submitted by the Quaker Oats Company (the petitioner). The amendment would expand the use of this health claim to some whole oat products that are currently ineligible. For example, “reduced sugar” flavored instant oatmeal products were ineligible for the oat beta-glucan health claim because they carried more whole oats as a result of the sugar reducing process and the fat from these additional oats pushed the fat content of these products past the limit for a “low fat” designation. Similarly, the formulation of flavored instant oatmeal products with “reduced sugar” made these products technically ineligible to bear the oat beta-glucan health claim because by reducing sugar, the products contain more whole oats (and fat from whole oats) per reference amount customarily consumed.
Comments in response to the proposed rule must be submitted to FDA on or before April 23, 2007. http://www.cfsan.fda.gov/~lrd/fr070206.html
Calcium/ Vitamin D and Osteoporosis Health Claims for Dietary Supplements On January 5, 2007, FDA published a proposed rule to amend the health claim characterizing a relationship between calcium and osteoporosis. Specifically, FDA has proposed to amend the rule to:
(1) Include vitamin D so that additional claims can be made for calcium and vitamin D and osteoporosis;
(2) Eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis;
(3) Eliminate the requirement that the claim not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population and that the claim identify the populations at particular risk for the development of osteoporosis;
(4) Eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; and
(5) Eliminate the requirement that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake when the level of calcium in the food exceeds a set threshold level.
Comments in response to the proposed rule must be submitted to FDA on or before March 21, 2007. www.fda.gov/OHRMS/DOCKETS/98fr/E6-21996.pdf