Two U.S. senators have asked the Food and Drug Administration (FDA) to finalize standards for a 2007 proposed rule for gluten-free food labels. In a letter to FDA Commissioner Margaret Hamburg, Senators Ron Wyden (D-Ore.) and Patrick Leahy (D-Vt.) claim the delay is “creating unnecessary confusion for consumers and uncertainty for agricultural producers.” Included as part of the Food Allergen Labeling and Consumer Protection Act of 2004, the proposed gluten-free labeling rule represents the last time “any significant action on this has been taken,” the lawmakers wrote, adding that “regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of ‘gluten free’ standards and labels provided by 3rd party groups.” Wyden also issued a July 21, 2011, press release asserting that “accurate and standard” labeling on gluten-free products is essential for those with Celiac disease—“a painful disorder stemming from the inability to properly digest the gluten found in breads.”
Category Archives Food and Drug Administration
A bipartisan group of lawmakers has called on the U.S. Food and Drug Administration (FDA) to stop the approval process for genetically engineered salmon. Fifteen members of the House of Representatives and eight members of the U.S. Senate signed separate letters to FDA Commissioner Margaret Hamburg expressing economic and environmental concerns over the fast-growing fish. “We are concerned that the FDA’s review of GE salmon uses the same criteria as it would for approving a veterinary drug,” noted the Senate letter, adding that “the lack of transparency in the approval process is extremely disconcerting given that approval of GE fish is likely the first step toward approval of many more GE animals for human consumption.” The House recently approved an amendment prohibiting FDA from using money to approve GE salmon applications in fiscal year 2012 and, according to the letters, similar language has been drafted for consideration by the Senate.…
Several consumer protection organizations have filed a citizen petition with the Food and Drug Administration (FDA), seeking a rulemaking “for labeling and point of sale advisories concerning mercury in seafood to minimize methylmercury exposure to women of childbearing age and children.” According to the petition, some 200,000 children in the United States, between ages two and five, have blood mercury levels nearly 50 percent higher than base levels recommended by the Environmental Protection Agency. Noting that the percentages of women and children exceeding recommended mercury levels are higher in coastal regions and among African-Americans, Asians, the affluent, and those in the fishing industry, the petition claims that consumers “do not know the risks inherent in exposing themselves and their families to this potent neurotoxin.” Jane Hightower, a physician who authored Diagnosis: Mercury—Money, Politics & Poison, signed the petition, which was also brought on behalf of Earthjustice, the Zero Mercury Working…
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced an expansion of the Salmonella Initiative Program (SIP) to help industry reduce foodborne pathogens in raw meat and poultry products. The agency has extended the comment period to September 12, 2011. According to FSIS, the voluntary, incentive-based program allows “participating establishments to operate under certain regulatory waivers to try new procedures, equipment or processing techniques to better control Salmonella.” As a condition for participation, establishments selected for SIP must regularly collect product samples to test for Salmonella, campylobacter and generic E. coli, and then share the data with the agency. FSIS has set new deadlines for establishments currently operating with regulatory waivers to apply for SIP and has allowed a “limited number of establishments to operate with modified line speed” which will be evaluated by a National Institute for Occupational Safety and Health study. See USDA…
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (IG) has issued a June 21, 2011, report criticizing the Food and Drug Administration’s (FDA’s) imported food recall guidance as “not adequate to ensure the safety of the nation’s food supply because it was not enforceable.” According to the audit, which covered the period from July 1, 2007, through June 30, 2008, “FDA oversaw 40 Class I recalls of imported food products contaminated with pathogens and other harmful substances that can cause serious illnesses.” After reviewing 17 of those recalls, the IG concluded that firms (i) “did not promptly initiate recalls,” (ii) did not submit viable recall strategies, (iii) “did not issue accurate and complete recall communications to their consignees,”, and (iv) “did not submit timely and complete recall status reports.” The report also faults FDA for the inconsistent application of its own monitoring procedures, including the…
A federal court in California has denied Safeway, Inc.’s motion to dismiss or stay proceedings alleging that it has an obligation to use information in its loyalty card customer database to provide email notice about produce recalls ordered by the Food and Drug Administration (FDA) or U.S. Department of Agriculture. Hensley-Maclean v. Safeway, Inc., No. 11-1230 (N.D. Cal., order entered June 13, 2011). Additional details about the case, which was first filed in state court, appear in Issue 380 of this Update. The grocery company argued that the “primary jurisdiction doctrine” or “equitable abstention” required the court to dismiss or stay the litigation “until and unless regulatory agencies have had the opportunity to consider and adopt appropriate rules governing the obligations a grocery store has with respect to providing its customers notice of such recalls.” According to Safeway, the Food Safety Modernization Act requires FDA to develop notice guidelines by…
Another tomato grower has filed a claim for damages against the Food and Drug Administration (FDA), alleging that the agency announced a nationwide recall of all tomatoes in the United States in 2008 without having identified tomatoes as the source of a Salmonella outbreak. Williams Farms Produce Sales, Inc. v. United States, No. 11-01399 (D.S.C., filed June 8, 2011). Details about similar claims also filed in a South Carolina federal court appear in Issue 395 of this Update. According to the complaint, FDA ultimately conceded that tomatoes were not the source of the Salmonella contamination, but not before the price for tomatoes plunged. Alleging negligence, defamation, slander of title, product/ commercial disparagement, unconstitutional taking, and violation of unfair trade practices law, the plaintiff seeks actual damages in excess of $11 million, special damages, compensatory damages, treble damages, attorney’s fees, and costs.
A coalition of non-profit advocacy organizations has filed a complaint for declaratory and injunctive relief against the Food and Drug Administration (FDA), alleging that the agency has unreasonably delayed action on several of its petitions relating to the use of antibiotics in animal feed. Natural Res. Def. Council v. FDA, No. 11-3562 (S.D.N.Y., filed May 25, 2011). The plaintiffs seek orders compelling the agency to “withdraw approval for subtherapeutic uses of penicillin and tetracyclines, unless FDA’s findings are reversed in new administrative proceedings.” According to the complaint, while FDA determined in 1977 that these drugs” have not been shown to be safe,” it never withdrew its approvals for the drugs’ subtherapeutic uses. Contending that “misuse and overuse of antibiotics has given rise to a growing and dangerous trend of antibiotic resistance,” the coalition alleges that some of its organizations filed citizen petitions in 1999 and 2005 requesting that FDA “withdraw approvals…
The Food and Drug Administration (FDA) is seeking public comment on a study examining labeling claims on whole-grain products. Titled “Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages,” the study is part of the agency’s “continuing effort to enable consumers to make informed dietary choices and construct healthful diets,” according to FDA. The study will examine (i) “consumer judgments about a food product including its nutritional attributes, overall healthiness, and health benefits”; (ii) “consumer judgments about a label in terms of its credibility in conveying the product’s nutritional attributes and its helpfulness in making product purchasing decisions”; (iii) “consumer perceptions about differences between different statements, such as ‘Made with Whole Grain,’ ‘Contains Whole Grain,’ and ‘Whole Grain”; (iv) “consumer extrapolation of whole grain statements beyond the scope of the statements themselves (i.e. halo effects)”; and (v) “how whole grain statements influence consumer use of the…
The Food and Drug Administration (FDA) has announced a public meeting to discuss inspections and compliance provisions of the recently enacted Food Safety Modernization Act (FSMA). Set for June 6, 2011, in Silver Spring, Maryland, the meeting will allow stakeholders to comment on FSMA’s implementation strategies regarding (i) “enforcement authorities”; (ii) “frequency and targeting of facility inspections”; (iii) “manner of inspection in a preventive controls environment”; and (iv) “improving the reportable food registry (RFR).” The meeting will also be available through live webcast, and FDA encourages early registration. Details of FSMA were covered in Issue 376 of this Update. See Federal Register, May 26, 2011.
