Regulatory Issues: The FDA agenda for 2005

As we begin 2005 and the second term of the Bush presidency, the U.S. Food and Drug Administration is under fire over the flu vaccine and the safety of prescription drugs. As recently pointed out in a Washington Post editorial, when many prescription drugs were withdrawn from the market in the past, the agency was accused of having sloppy approval procedures. When fewer drugs are withdrawn, the agency is accused of being too reluctant to hurt the drug companies.What does this mean for the food industry? There probably will be no direct impact, but it’s not good when FDA’s scientists are demoralized and the agency stands accused of being too friendly with a regulated industry.As in the past, FDA has a full agenda of food regulatory matters. In 2005, we can expect to see a final rule on recordkeeping required under the Bioterrorism Act. We can also expect to see full enforcement of the requirements of the Bioterrorism Act now that the grace period is over. FDA is expected to issue a proposed rule or an advance notice of proposed rulemaking on carbohydrate claims. This may define terms like “low carb” and “net carbs.” Hopefully, this will all be settled before the low-carb craze dies out.FDA will continue to work on revising its regulations governing good manufacturing practices (GMPs) for food. The agency will likely issue its final rule on dietary supplement GMPs, and this may provide something of a preview for the revamped food GMPs, although the new food GMPs will certainly be less stringent than the dietary supplement GMPs.Although not purely an FDA activity, the 2005 Dietary Guidelines for Americans will be issued jointly by the Dept. of Health and Human Services and the Dept. of Agriculture. They are expected in the early part of the year. The current dietary guidelines are summarized in the familiar food pyramid. No drastic changes are expected, but the guidelines will continue to recommend that Americans limit their consumption of fats and sweets.Also not an FDA activity, but of interest, the National Uniformity for Food Bill likely will be re-introduced in the 109th Congress. This bill would most likely establish federal pre-emption over Proposition 65 warnings on food labels or on shelves in California grocery stores. It would require any state wishing to adopt or maintain food labeling requirements that go beyond federal law to justify them in a petition to FDA. Its passage is certainly not assured, but its prospects are probably better than at any time in the past.In terms of staffing, FDA’s top lawyer, Daniel Troy, recently resigned. Troy was appreciated for, among other things, his interest in the proper application of the First Amendment’s free speech guarantee to food labels. During his tenure, FDA solicited public comment on its approach to promotional claims for foods, drugs and dietary supplements in light of recent First Amendment case law. FDA’s mere solicitation of public comments on this issue was criticized by some at the time who viewed it as an industry-friendly exercise. More sensibly viewed, it provided an opportunity for all to submit substantive comments and have their views placed on record and considered.One result of this exercise was the agency’s acceptance of “qualified health claims” on food labels. Under this new policy, a health claim that is not supported by enough scientific evidence to meet the “significant scientific agreement” standard established by Congress can still appear on a food label, if accepted by FDA and accompanied by a disclaimer or otherwise qualified.Troy was also known for instituting a policy whereby all FDA “warning letters” are reviewed by attorneys in the Office of Chief Counsel. They are not sent by regional field offices acting alone. This practice is expected to continue and can be viewed as a sensible effort to achieve consistency.In addition to a new chief counsel, we will probably see a commissioner named in 2005. Since the top spot was vacated by former Commissioner Mark McClellan early in 2004, Lester Crawford has held the position of acting commissioner. Conventional wisdom says at least two things about the commissioner. First, one will be nominated after the election, not before, so as to delay the expenditure of any political capital. This has proven true. Second, a commissioner that has been approved by the Senate enjoys more authority to make tough decisions. At the time of this writing, there are not printable predictions about who the new commissioner might be. I’d venture a guess that it might not be someone with extremely close ties to the drug industry.David Joy is a partner at the Washington, D.C. law firm of Keller and Heckman LLP. Visit the firm's web site at www.khlaw.com.