Newsletter Vol 7 No 1 Winter 97

Date	Reference	Description
1/4/96	61 FR 296-337	Health claim for oat products proposed. FDA has proposed to allow health claims on labeling of various oat products, such as oatmeal, to alert customers about the relationship between these products and coronary heart disease. This would represent the first health claim targeting a specific type of food, as opposed to a specfic nutrient or group of foods (i.e., calcium or fruits/vegetables).
1/30/96	61 FR 3118-3173	Olestra approved. FDA approved sucrose esterified with medium- and long-chain fatty acids (olestra, a/k/a sucrose polyester) as a replacement for fats and oils. Procter & Gamble Co. (Cincinnati, OH) requested the approval. Although olestra is approved as a direct food additive, foods containing it must bear warning labeling specified by FDA due to possible abdominal cramping and other concerns.
2/12/96	61 FR 5349-5354	"Healthy" may be redefined by FDA. The regulations in 21 CFR 101.65 define the term "healthy" and specify how it may be used in implied nutrient content claims. Now, in response to three petitions, FDA is considering revising its definition. Under a recent proposal, certain processed fruits, vegetables, and enriched cereal-grain products conforming to a standard of identity would be permitted to use this term.
3/4/96	61 FR 8372-8417	Color additive rules being upgraded. FDA is proposing to permanently list most of the color additive lakes that are provisionally listed in the current regulations.
3/5/96	61 FR 8752-8781	New FDA health claim rules for folate/neural tube defects. Under a revised 101.79, foods and dietary supplements may make health claims associating folate intake with reduced risk of certain birth defects.
3/5/96	61 FR 8781-8797	Enriched grain products must be fortified with folic acid. FDA has revised 10 standards of identity in Parts 136, 137, and 139 to require the addition of folic acid; by cross-reference, 3 other standards are also affected.
5/2/96	61 FR 19654-19578	FSIS command-and-control regulations to become performance standards. In the interests of flexibility, and to pave the way for HACCP implementation, FSIS is proposing to convert several stringent processing regulations to performance standards. This is part of the government's effort to streamline its rules.
5/2/96	61 FR 19578-19590	More FSIS changes. FSIS proposed to eliminate prior approval requirements for establishment drawings, equipment design, and most partial quality control programs.
6/3/96	61 FR 27771	Reinventing government initiative. During the past year, FDA has revoked several rules, including several standards of identity for oysters and grits; additional changes have been proposed. FSIS has announced plans to revise a significant percentage of its rules also.
7/9/96	61 FR 36154-36219	CGMP for infant formula. FDA has responded to legislative mandates by proposing comprehensive manufacturing, quality control, and testing procedures for infant formula makers.
7/25/96	61 FR 38805-38989	Meat and poultry HACCP rules finalized. FSIS has established comprehensive new requirements based on HACCP (hazard analysis and critical control point) principles. The final rules require sanitation SOPs, E. coli testing, and HACCP planning.
8/2/96	61 FR 40320-40332	Restaurant menus lose nutrient content and health claim exemptions. Since passage of NLEA, FDA has allowed restaurants certain leeway when making health or nutrient content claims on menus. However, the agency has had to reverse that policy in light of a court case and comments from the public.
8/3/96	H.R. 1627	Food Quality Protection Act. The FQPA was signed into law on August 3, 1996. Among other things, it revised the procedures for objecting to EPA decisions on pesticide tolerances. Section 408(g)(2)(A) of the Food, Drug, and Cosmetic Act (FDCA) now requires that 60 days, instead of 30, be provided for the filing of objections and requests for hearings. The FQPA also overhauls pesticide regulation by loosening a federal prohibition on minute traces of carcinogens in processed food that dates back to 1958 (the so-called Delaney Clause); at the same time, it toughens some protections for raw foods. Note that the Delaney Clause still applies to food additives; however, this bill essentially removes pesticide residues in processed food from being considered food additives.
8/7/96	61 FR 40963-40981	Small-business exemption for nutrition labeling codified in FDA regs. In 1993, Congress passed a bill exempting small businesses from nutrition labeling requirements as long as they met the criteria and submitted an exemption notice to FDA. The agency has now issued regulations codifying the exemption.
8/16/96	61 FR 42741-42762	Revised FDA guidelines for voluntary labeling. Under NLEA, nutrition labeling for raw fruits, vegetables, and fish is voluntary. FDA has revised its guidelines for the voluntary program to make them more consistent with the mandatory nutrition labeling rules that apply to most FDA-regulated foods. The agency has added new Appendices C and D to Part 101.
8/23/96	61 FR 43433-43447	Claims concerning tooth decay and sugar alcohols being allowed, bringing number of FDA-sanctioned health claims to nine. FDA has modified its nutrition labeling rules to authorize claims on the association between sugar alcohols and dental caries. A new 101.80 has been added to the agency's health claim regulations.
8/28/96	61 FR 44269	Pesticide actions in response to FQPA. On July 29, 1996 EPA revoked six pesticide regulations concerning four different pesticides; four of the tolerance revocations were based on a determination that they were inconsistent with the Delaney clause in Section 409 of the federal FDCA (see 61 FR 39528). In light of the FQPA signed into law on August 3, however, the agency extended the date for filing objections and delayed the revocations.
9/9/96	61 FR 47453-47459	Should all FSIS standards of identity and composition be revoked or revised? This is one of the many questions being asked by FSIS concerning the usefulness of standards of identity in today's rapidly diversifying marketplace.
9/12/96	61 FR 48102-48110	FDA may require labeling for all free glutamate, may set limits on "No MSG" claims. FDA is concerned that labels stating "No MSG" may be misleading in cases when the food does contain other varieties of free glutamate.
12/20/96	61 FR 67243-67260	Nutrient content claims for fat substitutes. FDA has propose to allow the use of labeling claims for food products based on the reduced availability of fat to the body because of use of a fat substitute ingredient.

	Message from the Chair
	Intellectual Property Update
	News on Continuing Education
	Membership Committee Report
	Symposia Planned for 1997 IFT Annual Meeting
	From the Secretary
	Graduate Student Paper Competition
	HACCP and Product Liability Actions
	1996 Year in Review: Key Regulatory and Statutory Actions
	Editor(s) wanted

	The Biotechnological Process Patents Act (BPPA, Public Law 104-41), signed into law on November 1, 1995, was passed as a response to court decisions which the Patent Office was using to reject patent applications for biotechnological processes. Although the Court of Appeals for the Federal Circuit (CAFC) has recently clarified the previous decisions which were being relied upon by the Patent Office, it will still be interesting to see how the courts reconcile the BPPA and the most recent CAFC decisions.
	In the area of trademarks, the Federal Trademark Dilution Act (Public Law 104-98) was signed into law on January 16, 1996. Before this Act, it was at times difficult for the owner of a famous trademark to effectively block the unauthorized use of its mark if there was no competition between the two entities or likelihood of confusion among consumers caused by the unauthorized use. However, an owner of a famous trademark, such as Coca-Cola , can now more easily prevent the use of its mark by others.
	In addition to the above-identified legislation, the U.S. Supreme Court in 1995 decided the case of Qualitex Co. v. Jacobson Products Co., 34 USPQ2D 1161 (1995). The issue was whether color alone is entitled to trademark protection, and the Court held that in certain circumstances it is. This decision implicates the food industry in at least two ways. First, a manufacturer may now be able to claim trademark rights in the color of its packaging if that coloring serves to identify the manufacturer. For example, Hershey Foods may be able to claim rights in its distinctive coloring of the packaging of its Reese's peanut butter cups. Second, a manufacturer may be able to claim rights to the color of a food product itself. This may be more difficult, however, since many food colors serve a function, such as the orange color of an orange flavored confection, and trademarks cannot cover functional features. However, if the color serves to identify the manufacturer, then the manufacturer should be able to claim trademark rights in that color.

	Dietary and Environmental Estrogens: Hormone Disrupters - co-sponsored with the Toxicology and Safety Evaluation Division
	Labeling Calorie-Reduced Macronutrients - co-sponsored with the Nutrition Division
	Technical and Legal Concerns with Bringing a New Product Idea to Market -co-sponsored with the Marketing and Management Division