Citing the need to protect the long-term health of children, U.S. Rep. Rosa DeLauro (D-Ct.) has introduced legislation (H.R. 2529) that would require the U.S. Food and Drug Administration to set a maximum permissible level for inorganic arsenic in rice and rice products within two years. “High levels of inorganic arsenic, a known carcinogen, can be found in rice, cereal and other common, everyday foods,” DeLauro said. “The federal government needs to step in to make sure that American families are consuming food that is safe.” The proposal has been referred to the Committee on Energy and Commerce and Committee on Agriculture. See Press Release of U.S. Rep. Rosa DeLauro, May 21, 2015. Issue 566
Category Archives Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has issued draft guidance about the implementation of mandatory food recall provisions under the Food Safety Modernization Act (FMSA). The guidance provides answers to common questions such as “What evidence might FDA consider when deciding to move forward with a mandatory food recall under Section 423 of the Federal Food, Drug, and Cosmetic Act?” Interested parties may submit comments to the Division of Dockets Management until July 6, 2015. See Federal Register, May 7, 2015. Issue 565
The Food and Drug Administration has announced a June 1, 2015, public meeting of the Transmissable Spongiform Encephalopathies (TSE) Advisory Committee in Silver Spring, Maryland. Presentations at the meeting will reportedly target the (i) current bovine spongiform encephalopathy (BSE) “situation” domestically and worldwide; (ii) U.S. Department of Agriculture’s regulatory approaches to decreasing the risk of foodborne exposure to BSE; and (iii) variant Creutzfeldt-Jakob Disease “situation” domestically and worldwide, and status of the U.K.’s Transfusion Medicine Epidemiological Review. Written comments must be submitted by May 25. See Federal Register, April 29, 2015. Issue 563
Days after the U.S. Food and Drug Administration (FDA) released a March 2015 letter warning Kind LLC against using the word “healthy” to describe several of its products, a consumer filed a class action against the company alleging negligent misrepresentation and violations of California consumer protection statutes. Kaufer v. Kind LLC, No. 15-2878 (C.D. Cal., filed April 17, 2015). The FDA Warning Letter listed the packaging of several products that an agency investigation apparently determined violated the Federal Food, Drug, and Cosmetic Act because the products’ nutrient contents do not meet federal requirements to be described as “healthy.” The letter also warned Kind against the use of “+” or “plus” as well as “No Trans Fats.” The putative class action complaint cites the FDA letter, arguing that the “healthy,” “+” or “plus” and “no trans fats” claims mislead consumers into believing that they are purchasing a healthful product. The plaintiff…
The Center for Science in the Public Interest (CSPI) and other organizations have filed a regulatory comment challenging the approval process for substances generally recognized as safe (GRAS) for use in food products, arguing that the U.S. Food and Drug Administration (FDA) has weakened the GRAS standards to the point that they violate the Food Additives Amendment of 1958. According to the comment, “[T]he American public would likely find it both disturbing and surprising that thousands of chemicals added to food today are not approved or even reviewed by FDA. Instead, of the roughly 10,000 additives currently used in food, more than 3,000 have never been substantively reviewed by FDA. For an estimated 1,000 of these substances, safety decisions were made by the food industry without any notice at all to FDA.” The comment further alleges that the agency has weakened food-safety laws with its 1997 proposal to change the GRAS…
Food & Water Watch (FWW) has released an April 2015 report alleging that the scientific research used by federal agencies to evaluate animal drug safety “is very heavily influenced by corporate drug companies.” In particular, the report alleges that there were “virtually no independent, peer-reviewed” safety studies on one drug used as a growth promoter that was eventually withdrawn from the marketplace. “Most of the available research examined commercial dimensions of Zilmax, such as the drug’s impact on beef qualify, and more than three-quarters of the studies were authored and/or funded by industry groups, almost all of which were published in scientific journals sponsored and edited by industry groups,” opines FWW in an April 8 press release. “Many academic journals have failed to establish or enforce rules requiring scientists to publicly disclose financial conflicts of interest, which has allowed deeply conflicted research to distort the scientific discourse.” Citing these issues,…
Attorneys in the U.S. Department of Justice and U.S. Department of Health and Human Services have filed a lawsuit against Wholesome Soy Products to permanently enjoin the company, its owner and manager from causing food to become adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA) after government agencies allegedly linked the company’s facilities to a 2014 outbreak of Listeria in Michigan and Illinois. United States v. Wholesome Soy Prods., Inc., No. 15-2974 (N.D. Ill., filed April 3, 2015). Wholesome Soy manufactured and sold mung bean and soybean sprouts until November 2014, when the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) and state agencies allegedly traced incidents of Listeria infections observed in five people to the Wholesome Soy facility. An FDA laboratory allegedly found Listeria in 28 samples—including two from mung bean sprouts—taken during a September 2014 inspection of Wholesome Soy’s plant and…
The U.S. Food and Drug Administration (FDA) will host a public workshop titled “FDA Science Forum 2015” on May 27-28 in Silver Spring, Maryland. The focus of the event will be highlighting science conducted at FDA, the role that research plays in informing regulatory decision making and providing a forum for collaborations with external organizations. The agency’s eight Regulatory Science priority areas include (i) ensuring FDA’s readiness to evaluate innovative emerging technologies, (ii) implementing a prevention-focused food safety system and (iii) strengthening social and behavioral science to help consumers and professionals make informed decisions about regulated products. Registration information is available on FDA’s website. See Federal Register, April 9, 2015. Issue 561
The U.S. Food and Drug Administration (FDA) has established a docket for comments related to the agency’s implementation of food safety standards mandated under the Food Safety Modernization Act (FMSA) and announced an April 23-24, 2015, public meeting in Washington, D.C., to solicit input about operational work plans. Operational work plan discussions will focus on produce safety, preventive controls for animal feed and food manufacturing facilities, measures to address intentional adulteration, the Foreign Supplier Verification Program, and FDA’s third-party accreditation program. Meeting participants will also have the opportunity to attend various break-out sessions on particular topics. Registration information is available on FDA’s website, and stakeholders may submit written or electronic comments to the docket by May 26. See Federal Register, March 24, 2015. Issue 560
The estate of Logan Stiner, an Ohio teenager who died in May 2014 after ingesting pure caffeine powder purchased from Amazon, has filed a lawsuit against the online retailer and the companies that manufacture and market the powder. Stiner v. Amazon.com Inc., No. 15CV185837 (C.P. Lorain Cty., filed March 6, 2015). According to the complaint, “pure caffeine is a drug” under Ohio law, but the powder manufacturers have “successfully avoided meaningful regulation of [the] product by the U.S. Food and Drug Administration (FDA) by classifying their product as a ‘dietary supplement,’” which leaves them “responsible for determining that pure caffeine powder is safe.” The companies “failed to alert users of the known risks and side effects of ingesting caffeine powder, including the risk of cardiac arrhythmia and cardiac arrest,” the reaction that killed Stiner, the complaint says. The estate also alleges that the companies did not conduct adequate testing of…
