The Food and Drug Administration said TWI Foods Inc., of Mississauga, Ontario, Canada, is voluntarily recalling Crispy brand cookies and Rusk, a hard crisp bread. According to the FDA, the affected products contain almonds and/or milk, two of the eight most common allergens, which are not clearly declared on the label. The Canadian-manufactured cookies products were sent to 28 U.S. distributors in 15 states, including California, Colorado, Florida, Georgia, Illinois, Texas, Virginia, Maryland, Massachusetts, New Jersey, New Mexico, New York, Ohio, Oregon, and Washington.

The Food and Drug Administration is alerting healthcare professionals that another cancer drug, originating from a foreign source and purchased by U.S. medical practices, has been determined to be counterfeit. FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab), an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the U.S. (it is an approved drug in Turkey). Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI).

Persuading regulatory agencies and industry associations in developed nations to share their food and drug safety inspection results is among the steps recommended by a Food and Drug Administration (FDA) report on ways to boost the safety systems in developing countries. The FDA and its “technologically advanced “counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand should devise a system for mutual recognition of one another's inspections, which would eliminate the wasteful duplication of effort, the report said.

The Environmental Protection Agency issued a final rule in the Federal Register that eliminates the need to establish a maximum permissible level for residues of Bacillus pumilus strain GHA 180 in or all food commodities. The agency was acting on a petition by Premier Horticulture seeking an exemption from the requirement of a tolerance for residues of the strain. Considerations for providing the exemption include the policy of harmonizing U.S. tolerances with international standards wherever possible, the EPA said. The agency considers international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA Sec. 408(b)(4), it said. Codex Alimentarius, which is recognized as an international food safety standards-setting organization, has not established a MRL for Bacillus pumilus strain GHA 180. The regulation will go into effect on or around May 30.

The Food and Drug Administration released two draft guidance documents that implement the provisions of the Family Smoking Prevention and Tobacco Control Act that aims to provide the public with previously unknown information about chemicals in tobacco products and helps prevent misleading marketing about the risks associated with tobacco products. The Act requires tobacco product manufacturers and importers to report quantities of harmful and potentially harmful constituents (HPHCs) found in tobacco smoke by brand and sub-brand. The new FDA documents list 93 HPHCs that tobacco companies will be required to report for every regulated tobacco product sold in the U.S. But realizing that industry may be unable to meet the reporting deadline because of current testing limitations, the agency identified 20 HPHCs that are "representative of the full list and for which testing methods are well established and widely available." The FDA said it intends to focus reporting enforcement on these 20 HPHCs in 2012. The first document provides guidance on how companies will comply with the reporting requirement and the second provides guidance on advertising or marketing a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.

The Natural Resources Defense Council (NRDC) said the Food and Drug Administration was “out-of-step with scientific and medical research,” when it rejected NRDC’s petition March 30 to ban bisphenol A (BPA) in food packaging. “The agency has failed to protect our health and safety -- in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children," said Sarah Johnson, senior scientist in the public health program at NRDC.

The Food and Drug Administration issued its weekly Enforcement Report for March 21, 2012 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

The Food and Drug Administration issued its weekly Enforcement Report for March 28, 2012 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

The Environmental Protection Agency issued a correction in the Federal Register to its final rule amending the significant new use of the chemical substance identified generically as tris carbamoyl triazine. When modifying the significant new uses for tris carbamoyl triazine, the EPA inadvertently included a reference that requires warnings for developmental effects, the agency said. The EPA did not intend to include this requirement when modifying the significant new uses for tris carbamoyl triazine and did not identify potential concerns for developmental effects in the proposed rule or final rule. The Federal Register notification corrects that typographical error, the agency said.

The Environmental Protection Agency is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for hexabromocyclodecane (HBCD). This proposed rule would designate “use in consumer textiles, other than for use in motor vehicles” as a significant new use. This action would require persons who intend to manufacture (including import) or process HBCD for use in covered consumer textiles to notify the EAP at least 90 days before commencing that activity. The general SNUR article exemption for persons who import or process chemical substances as part of an article would not apply.