FDA Explores New Policies
July 1, 2004
FDA Explores New Policies
by David W. DexterSr.
In March, U.S. Health and Human Services Secretary Tommy G. Thompson made headlines by releasing a new Food and Drug Administration (FDA) report outlining a strategy for combating the epidemic of obesity with a focus on the message, “calories count.” The report by FDA’s Obesity Working Group included recommendations to strengthen food labeling, educate consumers about maintaining a healthy diet and weight and encourage restaurants to provide calorie and nutrition information. While obesity is near the top of FDA priorities, ongoing regulatory enforcement, research and communication activities march on.
GMPs may Get Makeover.
In a speech before the National Food Policy Conference in May, Dr. Lester M. Crawford, acting administrator of the FDA, announced that the Agency will revise its current good manufacturing practice (GMP) regulations for food (21 CFR, Part 110).
“Since food GMPs are an integral part of the nation’s control over food safety problems it is essential that they adequately address the needs of today’s food processes and food-borne hazards,” Dr. Crawford told the audience which included SFA representatives.
“We believe this effort, like our work on current good manufacturing practices for medical products, will improve the safety of these products and create new opportunities for introducing better manufacturing techniques,” Crawford said.
Since the food GMPs were last revised in 1986, there have been significant changes in food production technology, as well as a better understanding of food-borne illnesses, FDA said in a statement. The agency plans to hold three public meetings this summer to receive data, information, and other input on food GMP modernization from stakeholders.
Serving Sizes to be Examined
Included among the 168 “A-list” goals set by the FDA for FY 2004 are reassessments of serving sizes. Specifically, FDA will publish an Advance Notice of Proposed Rulemaking to solicit comment on (1) whether to require food packages that can reasonably be consumed at one eating occasion to declare the whole package as a single serving, (2) which, if any, Reference Amounts Customarily Consumed (RACCS) of food categories need to be updated, and (3) whether to provide for comparative claims for smaller portions of identical foods.
Under its enforcement goals, and clearly in response to FDA’s “calories count” campaign, the Agency will issue “letters to manufacturers regarding inaccurate serving sizes and, as appropriate, issue letters concerning specific products.” FDA will also solicit comments on how to give more prominence to calories on the label.
FDA’s goal is to complete at least 90% of these “A-List” items by the end of the current fiscal year, September 30, 2004.
Epidemiological-Based Food Warning
On June 2, 2004, the FDA issued a statement on an investigation on what may have caused four outbreaks of illnesses in children related to meals served at several schools in Massachusetts beginning in May 2003 and occurring in a Revere, Massachusetts, school as recently as May of this year.
On the surface, it may not seem unusual for a federal agency responsible for the safety of much of the nation’s food supply to intervene in such a matter. However, what has gained attention to those who study FDA policy is that the agency is now implementing a new policy concerning the release of consumer alerts based solely on epidemiologic data.
“FDA’s new policy of issuing such consumer alerts is now being followed in situations where illness is present and a product is implicated in the illness outbreak,” said SFA General Counsel, Richard S. Silverman, Hogan & Hartson, L.L.P., who sought an explanation of the new policy from the FDA. “This public warning may or may not provide any indication as to whether a recall of the suspect product was being initiated by the company or requested by FDA,” Silverman said. “Obviously, public releases based solely upon epidemiologic data have enormous ramifications for the food industry.”
According to FDA, the new policy came about as a result of the agency’s conclusion that the public was not being well served if FDA had concerns about a product that was causing human illness but did not release such information to the public in a timely fashion.
In this outbreak the epidemiological investigation noted that the Revere, Massachusetts, school meals included tortillas produced by a Chicago-based tortilla company. Investigations and repeated laboratory analyses by FDA of the tortillas and ingredients have not identified any particular contaminant as the vehicle for these illnesses.