The Food and Drug Administration (FDA) has reopened the comment period for its 2005 interim final rule on the “Use of Materials Derived From Cattle in Human Food and Cosmetics,” which prohibited the use of certain cow components to prevent the potential risk of bovine spongiform encephalopathy (BSE) in human food and cosmetics. The interim final rule stated that a cow’s small intestine was safe for use in human food and cosmetics provided the distal ileum was removed. According to the agency, new scientific data confirms the presence of low levels of BSE in other parts of the cow’s intestine, including the proximal ileum. Interested parties can comment on the new studies until May 13, 2013. See Federal Register, March 4, 2013.
Category Archives Food and Drug Administration
According to a news source, the Food and Drug Administration (FDA), which has released for public comment just two of five major proposed rules to implement the Food Safety Modernization Act (FSMA), will allow the public to comment on all of them once they have all been made available. FDA spokesperson Shelly Burgess said, “We have received some feedback regarding this and FDA will adjust the comment periods to allow the opportunity for the public to comment as a package.” Thus, no comment period will close until all five rules have been published. Information about the initial proposals appears in Issue 466 of this Update. See Law360, March 5, 2013.
The Food and Drug Administration (FDA) has released for public comment a report on pilot projects established under the Food Safety Modernization Act (FSMA) “with the food industry to explore and evaluate methods for rapid and effective tracking and tracing of foods.” The report includes the recommendations of the Institute of Food Technologies, the agency’s project partner, on improving tracking and tracing of food, and FDA will use public comments on those recommendations in finalizing its report to Congress on the matter. Electronic or written comments are requested by April 4, 2013. See Federal Register, March 5, 2013.
The Food Safety and Inspection Service (FSIS) has issued a final rule, effective May 6, 2013, that amends federal meat and poultry products inspection regulations to remove sodium benzoate, sodium propionate and benzoic acid from the list of substances prohibited for use in meat or poultry products. According to FSIS, after considering the comments and petitions it received, as well as confirming that the Food and Drug Administration (FDA) had no objections to the safety of the substances, the agency has determined “that sodium benzoate, sodium propionate, and benzoic acid, under the conditions proposed in the petitions, are both safe and suitable for use as antimicrobial agents in certain RTE [ready-to-eat] meat and poultry products.” FSIS said that new uses of these substances in meat or poultry products will continue to be approved by FDA for safety and by FSIS for suitability. See Federal Register, March 7, 2013.
The Food and Drug Administration (FDA) has announced the availability of revised draft guidance related to the evaluation and safety of veterinary drug residues in human food. Both sets of guidance are part of the agency’s efforts under the Registration of Veterinary Medicinal Products to harmonize technical requirements for the approval of veterinary medical products in the European Union, Japan and the United States. The guidance titled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (ADI)” offers a plan for assessing “the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.” To this end, the guidance (i) “outline[s] the steps in determining the need for establishing a microbiological [ADI]”; (ii) “recommend[s] test systems and methods for determining no-observable adverse effect concentrations (NOAECS) and no-observable effect concentrations (NOAELs) for the…
The Food and Drug Administration (FDA) has released its “International Food Safety Capacity-Building Plan,” which aims to enhance “the food safety capacity of countries that export food to the United States.” As directed by the Food Safety Modernization Act, the plan provides direction on how FDA can (i) “expand the technical, scientific, and regulatory capacity of foreign governments and their food industries,” (ii) “prioritize its capacity-building efforts based on risks,” and (iii) “work in partnership with counterpart authorities, industry, and other organizations in order to achieve lasting food safety results.” To this end, the plan promotes efficiency across the Foods and Veterinary Medicine Program, evidence-based decision-making, the exchange of information between FDA and foreign government agencies, and enhanced technical support for foreign programs. “This capacity-building plan recognizes the need for a change in agency strategy,” states FDA’s report. “Instead of focusing primarily on intercepting harmful products, FDA will attempt to…
The Food and Drug Administration (FDA) has extended the comment periods on two proposed rules related to foodborne illness prevention and produce safety that appeared in the Federal Register on January 16, 2013. In response to a request for a 90-day extension, the agency has increased until May 16, 2013, the comment periods for the proposed rules titled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” Under the Food Safety Modernization Act, the two new rules would (i) require both foreign and domestic food manufacturers “to develop a formal plan for preventing their food products from causing foodborne illness,” and (ii) establish “science- and risk-based standards for the safe production and harvesting of fruits and vegetables.” Additional details about the rules appear in Issue 466 of this Update. See Federal…
The Food and Drug Administration (FDA) has announced that the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) have filed a petition requesting that the agency amend the standard of identity for milk and 17 other dairy products “to provide for the use of any safe and suitable sweetener as an optional ingredient.” FDA is seeking comments and other information by May 21, 2013. IDFA and NMPF have evidently asked FDA to amend the milk standard of identity to allow optional characterizing flavoring ingredients used in milk— such as chocolate—to be sweetened with any safe and suitable sweetener, including non-nutritive sweeteners such as aspartame. According to IDFA and NMPF, the proposed amendments “would promote more healthful eating practices and reduce childhood obesity by providing for lower-calorie flavored milk products.” In particular, the petitioners claim that lower-calorie flavored milk would assist “in meeting several initiatives aimed at…
During oral argument before a Second Circuit Court of Appeals panel, the Food and Drug Administration (FDA) reportedly argued that it had “no obligation” to complete proceedings that the agency initiated to withdraw approval from certain uses of antibiotic drugs in livestock. Natural Res. Def. Council v. FDA, No. 12-2106 (2d Cir., argued February 8, 2013). Assistant U.S. Attorney Ellen London said, “It’s completely discretionary as to when to enforce the law as to certain drugs,” in urging the court to reverse a district court order requiring it to hold the withdrawal proceedings announced in 1977 notices. According to a news source, one of the panel judges appeared to agree with FDA’s position, suggesting that it could, in theory, be forced to divert resources from high priorities on the basis of lawsuits filed against it. More information about lower court rulings in the case appear in Issues 432 and 442 of this…
The Food and Drug Administration (FDA) has announced two additional public meetings to discuss proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule), and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule). The meetings are scheduled for March 11-12 in Chicago and March 27-28 in Portland, Oregon. FDA anticipates that the proposed produce safety rule would “reduce foodborne illnesses associated with the consumption of produce.” The proposed preventative controls rule would evidently apply to human food and require domestic and foreign facilities that must register under the Federal Food, Drug, and Cosmetic Act to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, monitor results and act to correct problems that arise. See…
