The Natural Resources Defense Council (NRDC) and nearly two dozen Gulf Coast organizations have requested that the Food and Drug Administration (FDA) and National Oceanic and Atmospheric Administration (NOAA) “strengthen the current protocols and data relied on to determine whether seafood is safe for consumption and when to re-open areas for fishing” after the massive oil spill that occurred in the Gulf of Mexico. Now that some fisheries have reopened, NRDC is concerned that existing testing and assessment protocols are insufficient to protect human health and safety. The organizations call for the agencies to include chemical monitoring in their seafood analyses, contending that cadmium, copper, lead, and mercury have all been detected in crude oil studies. The August 17, 2010, letters request that the agencies (i) “ensure there is comprehensive monitoring of seafood contamination”; (ii) “ensure public disclosure of all seafood monitoring data and methods”; and (iii) “ensure that fishery…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has announced the availability of a draft compliance policy guide for FDA staff that provides direction on Salmonella in animal feed or feed ingredients that come into direct contact with people, such as pet food and treats, or that are “contaminated with a Salmonella serotype that is pathogenic to the target animal for which the animal feed is intended.” The guide “proposes criteria that should be considered in recommending enforcement action against animal feed or feed ingredients that are adulterated due to the presence of Salmonella.” FDA will accept comments until November 1, 2010. See Federal Register, August 2, 2010.
Food and Drug Administration (FDA) Commissioner Margaret Hamburg has released statements to support the reopening of Florida, Louisiana and Mississippi state waters to commercial fishing. According to Hamburg, “we are confident all appropriate steps have been taken to ensure that seafood harvested from waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish that will be coming out of this area.” Meanwhile, some are questioning whether inspector sniff tests are sufficient to ensure the safety of seafood from Gulf of Mexico waters. Experts reportedly say that the smell tests are an efficient and inexpensive way to test for fish safety and claim they are currently the only way to test fish for chemical dispersants. At least one oysterman and shrimp and crab fisherman was not convinced, saying, “If I put fish in a barrel and poured oil and Dove detergent…
The Food and Drug Administration (FDA) has solicited feedback on a proposed information collection related to the Pet Event Tracking Network (PETNet). PETNet would allow state and federal regulators “to quickly and effectively exchange information about outbreaks of illness in companion animals associated with pet food.” FDA has envisioned the voluntary system as a “secure, Internet-based network” that would provide a platform for members to receive and create alerts about pet food incidents. According to the agency, “The information will be used to help State and Federal regulators determine how best to use inspectional and other resources to either prevent or quickly limit the adverse events caused by adulterated pet food.” FDA has anticipated that each participating state would report via PETNet approximately 10 times per year. “[G]iven that the form only has 11 items and most are drop down fields, 20 minutes is a sufficient amount of time to…
The Food and Drug Administration (FDA) has issued a notice specifying the terms and conditions for voluntary compliance with section 4205 of the Affordable Care Act of 2010, which established nutritional labeling requirements for chain restaurants with more than 20 locations and vending machine operators with more than 20 machines. Other retailers not covered by section 4205 can elect to become subject to the federal law by registering biannually with FDA. Restaurants and similar establishments that voluntarily opt in “will no longer be subject to State or local nutritional labeling requirements unless those requirements are identical to Federal requirements,” according to the agency. Vending machine operators are already covered by state and local regulations identical to federal requirements, although Congress has “expressly provided” that they may still undertake voluntary registration. The agency will accept comments until October 21, 2010. See Federal Register, July 23, 2010.
The Food and Drug Administration (FDA) has called for comments on a proposed information collection included in a guidance document titled “Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition [CFSAN].” Under the National Environmental Policy Act of 1969, FDA must consider the environmental impact of its actions, including those related to food contact substance notifications; exemption requests for food additives; and petitions for GRAS affirmation, food additives and food colorings, food labeling, health claims, and nutrient content claims. FDA has since, however, amended its rulemaking to exclude certain classes of actions “that do not individually or cumulatively have a significant effect on the human environment.” Instead of routinely requiring information about the production of FDA-regulated articles, FDA has eliminated the previously required environmental assessment (EA) and provided guidance “to help industry submit a claim of categorical exclusion…
In response to an Office of Management and Budget (OMB) request, the Business Roundtable and The Business Council have prepared a report with a list of laws and regulations that the nation’s business leaders reportedly believe “have a dampening effect on economic growth and job creation.” Among the business groups’ concerns are proposals that would affect how the food and beverage sectors conduct business. Titled “Policy Burdens Inhibiting Economic Growth,” the report cited Food and Drug Administration food labeling policies, proposals to increase beverage taxes, pending changes to food safety laws, proposed nutrition standards, and youth marketing initiatives as areas of particular concern. OMB Watch, an organization dedicated to “equitable regulatory and budgetary processes,” questioned the timing of the White House invitation, claiming that recent economic and environmental catastrophes were due to lax regulation and not “because government has been too zealous.” Acknowledging that OMB may have initiated the dialogue as…
A federal court in New Jersey has reportedly stayed for six months consumer fraud litigation against the company that makes Arizona Iced Tea® beverages and has asked the Food and Drug Administration (FDA) to determine whether high-fructose corn syrup (HFCS) qualifies as a “natural” ingredient. Coyle v. Hornell Brewing Co., No. 08-2797 (D.N.J., stay order entered June 15, 2010). Claiming that these beverages are deceptively marketed as “100% Natural” despite containing HFCS, the plaintiff alleges violation of the New Jersey Consumer Fraud Act, unjust enrichment and common-law restitution, and breach of express and implied warranties. The court issued the stay rather than dismiss the putative class action outright as requested by the defendants on the basis of the doctrine of primary jurisdiction. According to a news source, the court acknowledged that “categorizing HFCS as either natural or artificial for the purpose of food and beverage labeling does not fall within…
As part of its ongoing campaign to persuade government authorities to prohibit the use of bisphenol A (BPA), the Natural Resources Defense Council (NRDC) recently filed a lawsuit in the D.C. Circuit Court of Appeals seeking to force the Food and Drug Administration (FDA) to take action on a petition the organization filed in October 2008 requesting that the agency prohibit the chemical’s use in food packaging. In re: NRDC, Inc., No. 10-1142 (D.C. Cir., filed June 29, 2010). One year ago, NRDC also submitted a petition to California EPA’s Office of Environmental Health Hazard Assessment, requesting that BPA be added to list of chemicals “known to the state to cause reproductive toxicity” under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Prop. 65). In its lawsuit, NRDC notes that more than 600 days have passed since its FDA petition was filed, and the NRDC reiterates…
The Food and Drug Administration (FDA) has submitted to the Office of Management and Budget a proposed information collection related to food labeling regulations. According to FDA, these regulations govern the submission of food labeling petitions and require food producers to: (i) disclose specific information about themselves or their products on labeling; (ii) retain records establishing the basis for the information contained on labeling; and (iii) provide these records to regulatory officials. The information collection notice provides estimated annual reporting and recording keeping burdens for these regulations. FDA has noted that it is no longer combining these burden hour estimates with those in information collections titled, “Food Labeling: Nutritional Labeling of Dietary Supplements on a ‘Per Day’ Basis” and “Food Labeling: Trans Fatty Acids in Nutrition Labeling,” although “[s]uch consolidation may occur in the future.” The agency will accept comments until August 16, 2010. See Federal Register, July 15, 2010.
