Imported Food Safety Act
On Oct. 10, Rep. John D. Dingell, D-Mich., introduced a bill in the House called Imported Food Safety Act of 2001, HR 3075. The original, pre-Sept. 11 problem catalyzing this proposed legislation was FDA confirmation that outbreaks of produce-related food-borne illness had increased in recent years. Since imported food presents a special problem, the bill would amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of food from foreign countries—including detecting the intentional adulteration of food. The bill was referred to the House Subcommittee on Health on Oct. 29, where it remained through the end of December.
This bill would include a provision authorizing the FDA to limit the ports of entry into the United States for foods. But this provision has generated intense industry opposition, particularly from the National Association for the Specialty Food Trade, based in New York, because it would cause huge backlogs at busy ports of entry and disrupt the time-sensitive delivery process that is essential for perishable foods. Some companies indicated that after Sept. 11 they already suffer one-week delays due to increased port inspections.
Public Health Security And Bioterrorism Response Act Of 2001
Following Sept. 11, new biosecurity measures were needed to combat bioterrorism. The latest bill to pass was HR 3448, the Public Health Security and Bioterrorism Response Act of 2001, which authorized $2.96 billion for fiscal year 2002. Passed in December, the bill included measures to safeguard the food supply by expanding inspection authority and record-keeping rules, plus registration of all food manufacturing, processing and packing and hold facilities (excluding restaurants). "It appears that the registration provision [will have] the greatest impact on our members," said David Seckman, executive director of the National Nutritional Foods Association. "Basically, any facility that manufactures or sells foods not to be eaten immediately ... will need to register with HHS [Department of Health and Human Services] or one of its agencies, perhaps as soon as 60 days after the bill's passage." A Senate version of HR 3448 is expected early this year.
Ginseng Truth In Labeling Act Of 2001
S 1664 and HR 3329, a specialized bill, was drafted primarily to require: 1) persons selling ginseng as a raw agricultural commodity to disclose its country of origin; and 2) importers of ginseng to disclose its country of origin at the point of United States entry. Retailers are exempted from additional labeling if the ginseng is appropriately labeled by the packer or importer. The bill also authorizes the agriculture secretary to impose penalties for violations of these requirements. Finally, the bill would amend the Federal Food, Drug, and Cosmetic Act to include a statutory definition of "ginseng" and provide for an enforcement plan to prohibit imported dietary supplements mislabeled as a ginseng product. On Nov. 8, the House bill was read twice and referred to the Senate Committee on Health, Education, Labor, and Pensions. On Nov. 16, the Senate bill was referred to the House Committee on Agriculture and the House Energy and Commerce Committee for consideration of provisions within the jurisdiction of each committee, respectively. On Nov. 28, it was referred to the Senate Subcommittee on Health for consideration as determined by the chair.
The CAM Commission
The White House Commission on Complementary and Alternative Medicine Policy was established on March 7, 2000. Its mission is to issue a comprehensive report, through the secretary of HHS, on legislative and administrative recommendations for assuring that public policy, in general, maximizes the benefits of complementary and alternative medicine for Americans. Part of this mission involves precluding erosion or dilution of the Dietary Supplement Health and Education Act. The Commission held a three-day conference, beginning Oct. 4, to discuss its "Interim Progress Report," and more recently held a two-day meeting, in part open to public comment.
On Dec. 6 and 7, the CAM Commission held a public meeting to discuss draft recommendations to be included in the Draft Final Report and the following key issues: coordination of CAM research; access to and delivery of CAM practices and products; coverage and reimbursement for CAM services and products; training and education for health care practitioners in CAM; development and dissemination of CAM information to the public; CAM in wellness, self-care and health promotion; and disease prevention. The overall focus of the commission is to ensure the public's access to safe and efficacious CAM services and products, and to reliable information. The CAM Commission's final report is due in March 2002.
New FDA Commissioner One event to watch for in Washington, D.C. is the nomination of a new commissioner to head the Food and Drug Administration, the post vacated by Jane Henney at the beginning of last year. At press time, the president was reported to have narrowed the selection to a short list of candidates—meaning two or three names. The process for approval of a new FDA commissioner works as follows:
- The secretary of HHS considers names and has discussions with the chairman and ranking member of the Senate committee that will ultimately give consent to the president's nominee, the Health, Education, Labor, and Pensions Committee.
- The president nominates a candidate.
- The candidate's name is sent to the Senate, which refers the candidate to the above-named committee.
- The Senate committee may or may not hold hearings before voting on whether to approve the candidate. A simple majority is required.
- If the candidate receives the support of the committee, the vote is then sent to the floor of the Senate for approval or rejection. A simple majority is required for approval. However, 41 opposing votes are sufficient to sustain a filibuster.
Earlier in 2001, there were two false starts to this selection process: In July, the Bush administration had been considering as commissioner two drug-industry executives (one from the biotech drug world). But seven of the 10 Democrats on the Senate committee reminded the president that the post traditionally goes to an M.D./academic or a career FDA official. The continued vacancies at the FDA, especially for commissioner, in turn provoked impatience from the president of the Biotechnology Industry Organization, who noted the practical effect on its member companies, which are awaiting review of their drugs in the drug approval process. Then in August, Secretary Tommy G. Thompson's top choice was rumored to be an industry lawyer rather than an M.D./scientist. This preference lasted until Sen. Edward Kennedy, D-Mass., and a majority of the Democratic senators on the approval committee he chaired, made it known that they would oppose any candidate without strong scientific credentials, and made it clear that they also objected to candidates from the industry.
FDA's 2002 Budget
Whomever the new FDA commissioner is, he or she will have a healthy and well-reasoned FDA budget to work with in 2002, including strong allocations for food and dietary supplements issues. On Nov. 29, the FDA announced that the president had signed a $1.4 billion budget for the agency in 2002 that broke records in many ways. For the first time in several years, Congress had provided an FDA budget over and above the increases requested for the Salaries and Expense account, $1.34 billion, funding a full pay raise of 4.6 percent for FDA employees.
Of interest are the following allocations (according to a Nov. 29 FDA press release):
- "$9.4 million to significantly upgrade food safety by expanding the highly successful Food Safety Initiative beyond microbiological contaminants to cover chemical and physical food hazards";
- $0.5 million to develop a database of women's health issues;
- and $15 million to keep mad cow disease out of the United States and thus to protect consumers against a new variant of the human infection linked to consumption of beef from cattle with bovine spongiform encephalopathy.
The agency's press release concluded: "These resources will allow FDA to continue its important role in effective health care delivery and ensure continued consumer confidence in the products we regulate."
Susan D. Brienza, Esq., is a Denver-based attorney with the Washington, D.C.-based national firm of Patton Boggs LLP. She practices in the areas of regulatory compliance in food and drug law and in advertising law and public policy.
Natural Foods Merchandiser volume XXIII/number 1/p. 1, 10