Legal & Regulatory Briefs

Supplement Labeling Petitions Submitted to FDA

Two petitions filed with FDA by the Council for Responsible Nutrition (CRN) and Amway Corp., and the American Herbal Products Association (AHPA), request that a provision in the agency’s final dietary supplement labeling regulations requiring the identity of the solvents used to extract dried herbs be revoked. The petitions say the rule is potentially misleading, and interested parties were not given notice and an opportunity to comment on it. AHPA also requested an extension of 30 days to file a petition for reconsideration of the provisions regarding quantification of liquid dietary ingredient extracts.

Oregon Department of Agriculture Calls for Expanded Klamath Blue-Green Algae Labeling

Concerned that Klamath Basin algae products may contain trace elements of the potent liver toxin microsystin, the Oregon Department of Agriculture has proposed a new labeling requirement for Klamath algae food and dietary supplement products. The new label would warn consumers against heavy consumption of the products.

USDA Spending on Organic Research Limited

Out of a total budget of $1.8 billion for agricultural research and education, USDA spending on research devoted to organic food production amounts to 0.01% or $1.5 million annually, according to a study released by the Organic Farming Research Foundation in Santa Cruz, CA. The study, which has already prompted action in Congress, found that out of 30,000 projects in USDA’s database, only 34 research projects focus on organic.

Petrou Foods Fined for Organic Violations

San Diego-based Petrou Foods was charged by the California Dept. of Health Services with 26 violations of the state’s 1990 Organic Foods Act. The company reportedly gets some of its olives from trees on a heavily fertilized golf course. Petrou could not verify sourcing and processing records, and inspectors found an altered certification document from the Organic Crop Improvement Association (OCIA) of Lincoln, NB, that actually belonged to another California firm.

NBTY Settles $8 Million Class-Action Lawsuit

Vitamin maker NBTY Inc. (NBTY) will pay $4.4 million in cash and $3.6 million in stock in an out-of-court settlement of a 1994 stockholder class-action suit alleging it artificially inflated sales, improperly capitalized costs and overstated inventory and accounts receivable. The proposed settlement requires court approval.