GRAS Under Fire As Consumers And Consumer Groups Focus On Food Safety

By Laurel Maloy, contributing writer, Food Online

Food manufacturers are creating their own panels of experts to make Generally Recognized as Safe determinations with the FDA’s blessing

What was the intention of Congress when the Generally Recognized as Safe (GRAS) exemption was created? First established in 1958, GRAS was a way to streamline the FDA approval process in regard to common food ingredients. At the time it was enacted, food ingredients were simpler, as were the processes by which the ingredients were derived. Not so today.

Competition for the consumer’s dollar has become so fierce, the fine balance between what is considered a trade secret and what can be disclosed to the public has become quite blurred. A prime example of this is Sweetmyx — a proprietary PepsiCo food additive. Sweetmyx will be used to boost the sweetness of sugar, enabling PepsiCo to use less sugar in its soft drinks than currently used. The World Health Organization’s (WHO) new guidelines on sugar intake have adversely affected many soda makers. Manufactured by Senomyx (SNMX), Sweetmyx has been cleared for use under the GRAS rule, as determined by the Flavor and Extract Manufacturers Association’s (FEMA) expert panel. FEMA calls itself, “the primary body for the safety evaluation of food flavoring for the flavor industry and the public.” They have even trademarked their GRAS program as FEMA GRAS. Can an entity such as this serve both the industry and the public at the same time or is a fox now guarding the henhouse?

Some of the Benefits of Membership include:

• A unique panel of experts available 24/7 to provide support and answer questions on matters such as international, federal, and state regulatory requirements and scientific issues related to flavors.
• FEMA will investigate sensitive issues and provide guidance and advice to its members wishing to remain anonymous.
• Guidance and advice is available to prepare members in advance of facility inspections by regulatory agencies.
• Active FEMA members are unique in their ability to support and benefit from the FEMA GRAS program, whereby the FEMA expert panel assesses the GRAS status of new flavor ingredients intended for use in the U.S. market.

The public is not mentioned anywhere within the benefits of membership, but international, federal, and state regulatory requirements and agencies are mentioned. Industry and U.S. markets are also mentioned, but benefits the group provides the public are nowhere to be found.

Groups, such as the Center for Food Safety (CFS), that advocate for food manufacturing transparency and safety are illuminating the GRAS process. In fact, CFS recently filed suit against the FDA in an effort to force the agency to do its job. According to the FDA’s Vision/Mission/Values, it is the agency’s duty to protect the consumer and enhance public health by maximizing FDA compliance. However, over the last 15 years, the FDA has allowed manufacturers to decide what is GRAS exempted. The GRAS provision leaves a wide open loop hole when it says, “Among qualified experts,” allowing manufacturers to empanel experts of their choosing — such as FEMA — for making GRAS determinations. Furthermore, there is no mandate for food manufacturers to submit GRAS determinations for review by the FDA; it is a voluntary process, one which enables trade secrets to remain just that, secretive.

Learn how to survive an audit from the FDA

Robert McQuate, CEO of GRAS Associates, a food ingredient-consulting firm, says that about half of his clients do not voluntarily submit GRAS determinations to the FDA for review. “GRAS information submitted to the FDA becomes publicly available,” he explains, so the main reason his clients do not submit GRAS determinations is to protect their trade secrets. “Confidentially is a significant issue…,” McQuate adds.

What was the intention of Congress when the Generally Recognized as Safe exemption was created? Was it to protect trade secrets at the expense of the public? According to Obama’s recent budget proposal, FDA funding, and therefore, the public health, is not a priority.