The U.S. Government Accountability Office has issued a report related to its review of the federal government’s oversight of pesticide residues in food. More specifically, the report discusses the congressional watchdog’s analysis of Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) Food Safety and Inspection Service and USDA Agricultural Marketing Service pesticide residue data, the data’s reliability, and the agencies’ methods for sampling foods for testing. Among other things, GAO recommends improvements in FDA’s methodology and disclosure of the limitations in both agencies’ monitoring and data collection efforts. Issue 544
Category Archives Food and Drug Administration
Sazerac Co. has recalled its Fireball Cinnamon Whiskey from Sweden, Norway and Finland because some batches contain levels of flavoring chemical propylene glycol that exceed European limits. The company says that it mistakenly shipped batches to Europe that were intended for the United States, where the U.S. Food and Drug Administration (FDA) allows higher levels for the Generally Recognized As Safe ingredient. The recall drew media attention to the regulation discrepancy, with many noting that industrial-grade propylene glycol is used in antifreeze. The company clarified October 29, 2014, that it uses food-grade propylene glycol, which it says is also used in many other consumable products, including salad dressing, beer, ice cream, and cake. Sazerac called the ingredient “ideal for use in a large variety of flavors to give most of today’s food and beverages their distinctive taste. Flavor companies use it to carry flavor ingredients through to the final product,…
Food & Water Watch and the Center for Food Safety (CFS) have reported that AquaBounty Technologies has been fined $9,500 USD for violating environmental regulations in Panama and call for the U.S. Food and Drug Administration (FDA), which is assessing the safety of the company’s genetically engineered (GE) salmon, to terminate its review and deny AquaBounty’s pending application to sell GE fish in the United States. The Panamanian National Environmental Authority apparently ruled on October 23, 2014, that AquaBounty failed to secure the permits needed for water use and water discharge before commencing operations. The decision came in response to a complaint filed in 2013 by the environmental organization Centro de Incidencia Ambiental. CFS senior attorney George Kimbrell said, “AquaBounty has not been able to follow the law, because it lacks the capacity, sophistication, will, or all of the above. This decision is also even further proof that FDA is…
The U.S. Federal Trade Commission (FTC) has filed a complaint in a New Jersey federal court against Gerber Products Co., alleging that since 2011 the company has falsely promoted its Good Start Gentle infant formula as a product that can prevent or reduce the risk of a child developing allergies. FTC v. Gerber Prods. Co., No. 14-6771 (U.S. Dist. Ct., D.N.J., filed October 29, 2014). The formula is apparently made with partially hydrolyzed whey proteins (PHWPs) that Gerber purportedly claims make the product easier to digest than formula made with intact cow’s milk protein. Product stickers and ads compare the product to breastfeeding as a way to naturally protect a baby from allergies and claim that the formula is the “1st and ONLY” “TO REDUCE THE RISK OF DEVELOPING ALLERGIES.” The company also allegedly claims that the formula “is the first and only infant formula that meets the criteria for…
The U.S. Food and Drug Administration (FDA) will host a public meeting and is soliciting public input on whether to expand the products included in its guidance, titled “Toxicological Principles for the Safety Assessment of Food Ingredients”—also known as the “Redbook.” The agency is apparently considering this expansion “to include chemical safety assessments for all products over which FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has statutory authority including regulatory contexts such as food additives, food contact substances, dietary supplement ingredients, food contaminants, and cosmetics.” According to FDA, “The Redbook would describe toxicological principles which apply across regulatory categories while still providing specific guidance for applying these principles within each particular context. The safety of foods containing microbial contaminants will continue to remain outside of the scope of the Redbook.” The meeting will take place December 9, 2014, in College Park, Maryland, and those wishing to participate in…
The U.S. Food and Drug Administration (FDA) has denied two citizen petitions asking the agency to prohibit the use of aspartame as a non-caloric sweetener. Dated July 16, 2002, the first petition argued that the Public Health Security and Bioterrorism Preparedness Response Act authorizes FDA to recall dangerous chemicals without manufacturer approval. Citing studies conducted by the European Ramazzini Foundation (ERF), the second petition urged FDA to revoke approval for the sweetener under the Delaney Clause in section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act, which provides that “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.” Responding to these claims, FDA reasoned that the first petition and subsequent comments…
According to a proposed consent decree filed in a D.C. district court, the U.S. Food and Drug Administration (FDA) will “submit a final rule regarding ‘Substances Generally Recognized as Safe’ [GRAS] to the Federal Register for publication no later than August 31, 2016.” Ctr. for Food Safety v. Burwell, No. 14-0267 (U.S. Dist. Ct., D.D.C., consent decree filed October 20, 2014). The Center for Food Safety apparently brought the action over concerns that food makers have been able to use an interim GRAS process and secure agency approval for allegedly unsafe ingredients, such as volatile oil of mustard, “olestra” and “quorn,” based on self-assessments. According to the Center’s complaint against the agency, FDA has unlawfully exempted GRAS substances from regulation as food additives under a rule proposed, but never finalized, some 15 years ago. That proposed rule purportedly eliminated a petition process requiring food companies to demonstrate that a substance satisfies…
The Government Accountability Office (GAO) has released a report assessing the U.S. Department of Agriculture’s (USDA’s) current approach to Salmonella and Campylobacter in chicken and turkey products and recommending that the agriculture secretary direct the Food Safety and Inspection Service (FSIS) to take steps to improve the approach. The report reviews past USDA action on these pathogens, including the establishment of standards limiting Campylobacter contamination and the tightening of existing Salmonella contamination standards. GAO recommended that the agriculture secretary direct FSIS to develop Salmonella and Campylobacter performance measures to monitor whether efforts to bring processing plants into compliance with the poultry products standards are meeting the agency’s goals. GAO also recommended that effectiveness measures be included in future revisions of compliance guidelines for controlling the pathogens. According to the report, USDA agrees with the recommendations. Issue 542
The U.S. Food and Drug Administration (FDA) has scheduled a November 13, 2014, public meeting in College Park, Maryland, to solicit stakeholder comments and respond to questions about revisions to four rules first proposed in 2013 to implement the Food Safety Modernization Act (FSMA). The proposals address (i) Preventive Controls for Human Food, (ii) Produce Safety, (iii) Preventive Controls for Animal Food, and (iv) Foreign Supplier Verification Programs. Information about registration and making oral presentations may be found at FDA’s website. See Federal Register, October 23, 2014. Issue 542
Agribusiness & Food Safety Associates Ann Havelka and Jara Settles have co-authored an article titled “FDA Warning Isn’t Enough Proof for Takings Claim” published on October 17, 2014, by Law360. The authors discuss a recent Court of Federal Claims ruling that rebuffed a takings claim filed by tomato growers who alleged that a 2008 Food and Drug Administration (FDA) warning about a Salmonella outbreak purportedly associated with certain raw red tomatoes caused tomato sales to decline dramatically. The outbreak was eventually linked to Mexican peppers. The article concludes that while the plaintiffs may have focused on the wrong argument to support their claims, the ruling “should prevent a flood of takings claims in the wake of garden-variety governmental warnings,” which, the authors contend, will allow FDA the flexibility it needs to protect public health. Additional information on the ruling appears in Issue 539 of this Update. Issue 542
