U.S. Senator Barbara Boxer (D-Calif.) has urged the Food and Drug Administration (FDA) to take action to address seafood fraud. In her October 15, 2012, letter, Boxer defines seafood fraud as “the mislabeling of one species of fish for another fish that is often cheaper and more readily available.” Boxer cites studies purportedly showing that the practice may be “pervasive” throughout the United States and contends that it not only constitutes “deceptive marketing, but it can also pose serious health concerns, particularly for pregnant women seeking to limit exposure to heavy metals or individuals with serious allergies to certain types of fish.” Among the studies cited are those finding mislabeled 20 percent of 88 samples tested in Boston, 55 percent of 119 samples tested in California and 31 percent of 96 samples tested in Florida. The senator expresses her concern with the low number of inspections FDA conducts on both imported…
Category Archives Food and Drug Administration
While foreign and domestic food facilities, including farms, must renew their registrations with the Food and Drug Administration (FDA) beginning October 1, 2012, under the Food Safety Modernization Act, the agency is not accepting registration renewals at this time. Facilities required to be registered under the law are asked to check FDA’s website to learn when the system becomes available,
The Food and Drug Administration (FDA) has extended the comment period for an advanced notice of proposed rulemaking (ANPR) that announced potential changes to regulations governing new antimicrobial animal drug reporting. The ANPR proposed altering these regulations to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). FDA has requested public comments “on how best to compile and present the summary information as directed by ADUFA 105, and on alternative methods available to the Agency for obtaining additional data and information about the extent of antimicrobial drug use in food-producing animals.” FDA has extended the comment period at the request of responders until November 26, 2012. See Federal Register, September 26, 2012.
The Food and Drug Administration (FDA) has announced a November 7-8, 2012, public workshop at Oklahoma State University in Stillwater “to provide information about food defense as it relates to food facilities such as farms, manufacturers, processors, distributors, retailers and restaurants.” Intended to help businesses better comply with the Public Health Security and Bioterrorism Preparedness Act of 2002, the workshop will cover the following topics: (i) “Food defense awareness and definitions”; (ii) “FDA food defense tools such as ALERT and Employees FIRST”; (iii) “Regulations mandated by the Bioterrorism Act”; (iv) “Food Defense Guidance from the Food Safety and Inspection Service”; (v) “Investigating food-related incidents effectively”; (vi) “Physical plant security”; and (vii) “Crisis management.” FDA has asked interested parties to register by October 31, 2012. See Federal Register, September 27, 2012.
After testing more than 200 rice products, Consumer Reports purportedly found levels of total arsenic, both organic and inorganic, far in excess of the federal limit of 10 parts per billion (ppb) for arsenic in drinking water. Among the products tested were baby cereals, crackers, milk, pasta, flour, and an array of brown, white and basmati rice. One infant cereal product apparently contained up to 329 ppb of arsenic. Consumer Reports recommended that consumers cook their rice in twice the amount of water, 6 cups to 1 cup of rice, eat a varied diet and experiment with other grains that are less prone to absorbing arsenic from soil and water as they grow. Its investigation included a data analysis by researchers experienced in National Health and Nutrition Examination Survey (NHANES) analyses. They found that of 3,633 rice consumers who participated in NHANES, those consuming one rice food item before their urine…
The Food and Drug Administration (FDA) recently published a notice seeking “any industry organizations interested in participating in the selection of a nonvoting industry representative to the Transmissible Spongiform Encephalopathies Advisory Committee [TSEAC].” Organizations that wish to participate in the selection of this nonvoting member should submit a letter stating their interest to FDA by October 18, 2012. The agency has also requested nominations for the post by the same date. FDA has charged TSEAC with reviewing and evaluating “the available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health.” The committee includes 15 voting members “knowledgeable in the fields of clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, and other related professions.” See Federal Register, September 18, 2012.
Consumer organization Public Citizen has filed a citizen petition with the Food and Drug Administration (FDA) challenging its policy of instructing staff, when responding to requests under the Freedom of Information Act (FOIA), to not consider “minor deletions,” which can be up to 20 percent of the responsive documents, as a partial FOIA denial that would trigger a requester’s right to an administrative appeal. Public Citizen specifically requests that FDA revoke 21 C.F.R. § 20.49(d) which states, “Minor deletions of nondisclosable data and information from disclosable records shall not be deemed a denial of a request for records.” The organization also asks the agency to revoke parts of its staff manuals. According to the petition, more than 20 years ago, the General Accounting Office (now the Government Accountability Office) (GAO) “urged FDA to rescind its deletions regulation and a similar policy on ‘minor deletions’” because it violates FOIA. Attached to…
The Food and Drug Administration (FDA) has announced a draft compliance policy guide (CPG) concerning the “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats.” According to the September 10, 2012, Federal Register notice, the draft CPG explains how FDA plans “to use its enforcement discretion with regard to the labeling and marketing of dog and cat food products that are labeled and/or marketed as intending to diagnose, cure, mitigate, treat, or prevent diseases and to provide nutrients in support of meeting the animal’s total daily nutrient requirements.” Issued in response to new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the draft CPG seeks to address an observed increase in the number of cat and dog food products “that make labeling or marketing claims” about disease diagnosis, treatment or prevention. It also…
Senators Richard Durbin (D-Ill.) and Richard Blumethal (D-Conn.) have responded to the Food and Drug Administration’s (FDA’s) letter concerning actions the agency plans to take on energy drinks. While the senators “were pleased to learn that the FDA intends to release final guidance distinguishing liquid dietary supplements from beverages,” they contend that FDA’s response to their earlier request “did not address one of our greatest concerns, which include the potential interactions and cumulative effects of additives with stimulant properties in energy drinks with high levels of caffeine. While ginseng and other additives were not mentioned, your letter reviews taurine and guarana, which are generally regarded as safe (GRAS) food additives when used to add flavor.” The senators seek an explanation about the use of these ingredients to provide a stimulating effect and their safety when used this way. They also seek information about the agency’s consideration of “the unique health…
The Center for Food Safety and Center for Environmental Health have filed a complaint for declaratory and injunctive relief against the Food and Drug Administration (FDA) alleging that the agency has unlawfully delayed adopting implementing regulations under the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., filed August 29, 2012). According to the complaint, FDA has missed seven statutory deadlines thus “failing to implement FSMA’s major food safety regulations.” Characterizing the failure as “an abdication of the agency’s fundamental responsibilities,” the plaintiffs claim that this delay “is putting millions of lives at risk from contracting foodborne illnesses.” They also sued the Office of Management and Budget, claiming that it has also missed statutory deadlines in failing to approve the implementing regulations that FDA has submitted for its review. The complaint recites Centers for Disease Control and Prevention estimates that one in six Americans…
