The Food Allergen Labeling and Consumer Protection Act (FALCPA), which requires the plain English labeling of eight major allergens, also directed the Secretary of Health and Human Services to consider and propose a definition of “gluten-free.” Persons with celiac disease or celiac sprue or gluten-sensitive enteropathy, which has no cure, are advised to avoid all sources of gluten (a protein in certain cereal grains). The FDA has published its proposed rule defining “gluten free” and other terms (72 FR 2795; 1/23/07). Comments will be accepted at least until April 23, 2007.

The proposal would define:

1. “gluten” as:

 . . . proteins that naturally occur in a prohibited grain (a defined term) and that may cause adverse health effects in persons with celiac disease 101.91(a)(2).

2. “prohibited grains” as:

wheat (Triticum); rye (Secale); and barley (Hordeum); and crossbred hybrids of the three grains; but not including “oats” and “millet,” which could be marketed as “gluten free” if the finished product contains less than 20ppm gluten 101.91(a)(1).

3. “gluten free” as:

a food which does not contain:

- a prohibited grain.

- an ingredient from a prohibited grain which has not been processed to remove the gluten.

- an ingredient from a prohibited grain which has been partially processed to remove the gluten, but gluten levels remain above 20ppm.

- 20ppm or greater gluten. (20ppm appears to be the limit of detection using existing methodology, none of which has been Association of Official Analytical Chemists [AOAC]-approved.)

4. a food which is naturally free of gluten (milk, vegetables and fruits) could claim, for example, “Milk—a gluten-free food” but could not be labeled as “Gluten Free Milk.”

Other ingredients in the proposal:

Although “oats” are not included in the list of “prohibited grains” because oats often are mixed with or present with “prohibited grains,” the FDA proposal does not permit an “Oats- a gluten-free food” label claim.

The proposal identifies hydrolyzed wheat protein, wheat bran and malt vinegar, among others, as examples of ingredients from which a portion of the gluten (protein) has been removed but an insufficient amount to qualify at the 20ppm level.

The proposal identifies modified wheat starch and wheat starch as ingredients which could be used in a “gluten-free” product, as gluten has been removed below the 20ppm threshold.

The proposal goes on to raise a number of additional and relevant questions for comment. The limits of detection and analytical methodology are both issues open for comment.

Fresh Produce Safety

The FDA has announced that it plans to hold two public hearings to discuss the safety of fresh produce. The notice is clearly in response to recent outbreaks, seeking information on these outbreaks and information on the general sanitary condition of the fresh produce industry.

The notice outlines areas for discussion and input:

Supply chain issues relating to sanitation and product safety.

Opportunities for federal interventions to promote sanitation and safe handling.

Traceability—FDA notes that several stops in the supply chain—from farms to restaurants/foodservice—are not currently within the recordkeeping purview of the FDA.

Are plans and procedures in place to deal with fresh produce safety issues, as they are for other types of food products?

How can farmers, markets, distributors and end users not currently in the inspection and control stream be effectively brought into a food safety system for fresh produce?

Comments are due by June 13, 2007.