FDA this week released a progress report on the Food Protection Plan launched in November 2007 to address “both food safety and food defense for domestic and imported products.” The report states that federal regulators are "working collaboratively across the agency to implement the three-core elements of protection: prevention, intervention and response.” It particularly notes that FDA has (i) established offices in China and India, with the intention of expanding its presence in Europe, Latin America and the Middle East; (ii) developed melamine and cyanuric acid testing for animal feed; (iii) developed rapid detection methods for E. coli and Salmonella; (iv) enhanced its ability to track foodborne illness outbreaks; (v) signed cooperative agreements with six states to form rapid response teams to handle emergencies; and (vi) approved the use of irradiation for iceberg lettuce and spinach. FDA also inspected 5,930 high-risk domestic food establishments in fiscal year 2008 and plans…
Category Archives Food and Drug Administration
FDA has reportedly opened the first of several overseas offices in Beijing, China, where eight U.S. officials described as “inspectors and senior technical experts in foods, medicines and medical devices” will work with Chinese regulators to improve export safety. FDA plans to launch two additional branches in Shanghai and Guangzhou, as well as expand its presence in India and Latin America. The agency will also train and certify third-party inspectors to ensure the safety of products bound for the U.S. market. FDA has lately come under fire for failing to “[keep] pace with the growing number of food firms,” according to the U.S. Government Accountability Office, which said federal regulators have “little assurance that companies comply with food-labeling laws and regulations.” Furthermore, China’s reputation has suffered both domestically and abroad as reports of melamine-tainted infant formula and agricultural products continue to surface. “We're opening up a new era, not just new…
FDA’s Center for Food Safety and Applied Nutrition (CFSAN) will conduct a roundtable discussion with stakeholders on December 12, 2008, and is tentatively scheduled to “communicate FDA’s nutrition activities” and provide status updates on functional foods, health claims, evidence-based review guides, Critical Path Project on Biomarkers for Use in Health Claims, front-of-pack labeling, and sodium status, among other matters. According to CFSAN, the format will consist of a panel of experts led by the agency’s director, with remarks from David Acheson, FDA Associate Commissioner, and a question and answer session. See CFSAN Constituent Update, November 7, 2008.
The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have announced a November 4, 2008, public meeting to consider agenda items coming before the 17th Session of the Codex Alimentarius Committee on Food Import and Export Inspection and Certification Systems (CCFICS). Slated for November 24-28 in Cebu, Philippines, the Codex session will address (i) the proposed draft “Principles and Guidelines for the Conduct of Foreign On-Site Audits and Inspections;” (ii) the proposed draft “General Model Health Certificate;” and (iii) the annex to the “Guidelines for Design, Production, Insurance and Use of Generic Official Certificates.” In addition, the committee will discuss “the need for guidance for national food inspection systems, the need for further guidance on traceability and product tracing, and the development of guidance on the prevention of international contamination of food,” according to USDA. Codex was formed in 1963 by the United Nations, the Food and…
A subcommittee of FDA’s Science Board has released its peer review of the agency’s draft assessment of bisphenol A (or BPA) for use in food contact applications. The FDA’s draft assessment concluded, on the basis of industry-funded studies, that “an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.” Further information about the draft assessment appears in issue 272 of this Update. According to the peer review, scheduled to be reviewed by FDA’s Science Board on October 31, 2008, the FDA properly focused on dietary exposures to children, “because they are likely to have both greater exposures and susceptibility than adults as a function of food consumption patterns, metabolism, vulnerability of developing systems and other factors.” The peer review then criticizes the agency’s assessment for its lack of “an adequate number of infant formula samples” and reliance “on mean values rather than accounting…
GAO recently presented a new report, titled Food Labeling: FDA Needs to Better Leverage Resources, Improve Oversight, and Effectively Use Available Data to Help Consumers Select Healthy Foods before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. The report claims that FDA oversight, which has failed to keep pace with the growing number of food firms, offers “little assurance that companies comply with food labeling laws and regulations for, among other things, preventing false or misleading labeling.” In particular, GAO found that FDA (i) “does not have reliable data on the number of labels reviewed”; (ii) conducted only “limited” testing for the accuracy of nutrition information for labels from 2000 through 2006; and (iii) “does not track the complete and timely correction of labeling violations or analyze these and other labeling oversight data in routine reports to inform managers’ decisions, or ensure the…
A GAO report has claimed that the Food and Drug Administration (FDA) “examined less than 1 percent of the 7.6 million fresh produce lines imported from fiscal years 2002 through 2007.” “Moreover, FDA acknowledged that it has not yet been able to conduct certain fresh produce work crucial to understanding the incidence of contamination of produce by pathogens such as E. coli O157:H7 or Salmonella,” according to GAO, which attributed the failures to a lack of resources for either extramural research grant programs or internal research agendas. The report also noted that the agency “has no formal program devoted exclusively to fresh produce” and has not “reliably tracked its fresh produce spending. “What I found most interesting is that fresh produce has been a priority for FDA for nearly a decade, but all the initiatives the agency said it needs to implement to improve its oversight efforts have been delayed because…
FDA has issued a final rule “amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis.” Effective January 1, 2010, the rule would also eliminate (i) “the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis”; (ii) “the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis”; (iii) “the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional”; and (iv) “the requirement that the claim…
The Food and Drug Administration (FDA) this week issued the results of “its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant food.” Prompted by “reports of melamine contamination in milk-derived ingredients” manufactured in China, FDA reviewed its scientific literature on melamine toxicity, pointing to “gaps in our scientific knowledge” regarding the threshold at which the industrial chemical becomes dangerous in infants. “There is too much uncertainty to set a level in infant formula and rule out any public health concern,” according to an October 3, 2008, FDA press release, which noted that for other food products, “levels of melamine and melamine-related compounds below 2.5 parts per million do not raise concerns.” Meanwhile, U.S. officials have reportedly located more melamine-tainted candy from China in New Haven, Connecticut, where two specialty stores were selling the White Rabbit Creamy Candy brand implicated in the global dairy scandal.…
In a July 3, 2008, letter to the Corn Refiners Association, the FDA has indicated that products containing high-fructose corn syrup (HFCS) may be labeled “natural” if the synthetic fixing agent that is used in the HFCS production process does not come into contact with the high dextrose equivalent corn starch hydrolysate, which undergoes enzymatic reaction to produce HFCS. The fixing agent apparently holds the enzyme in place on a column and any unreacted agent is removed by washing before the starch hydrolysate is added. Thus, “we would not object to the use of the term ‘natural’ on a product containing the HFCS produced by the manufacturing process described” by a representative of the Archer Daniels Midland Co., who met with FDA at the request of the Corn Refiners Association in April 2008. The agency added, “we would object to the use of the term ‘natural’ on a product containing…
