Category: FDA
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Advocacy Groups Seek to Ban Eight Substances Under Delaney Clause
A June 10, 2015, petition filed by consumer and environmental groups asks the Food and Drug Administration (FDA) to ban the following synthetic substances widely used in baked goods, ice cream and beverages: (i) benzophenone (also known as diphenylketone); (ii) ethyl acrylate; (iii) eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol); (iv) myrcene…
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Government Agencies Should Define “Natural” to Avoid Inconsistent Court Decisions, Professor Argues
In a recent journal article, a Babson College marketing law professor discusses legal disputes over the labeling of food as “natural,” noting drawbacks of using courts as public policy developers on the issue. Ross D. Petty, “‘Natural’ Claims in Food Advertising: Policy Implications of Filling the Regulatory Void with Consumer Class Action Lawsuits,” Journal of Public…
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DeLauro Proposal Would Establish Regulatory Tolerance for Inorganic Arsenic in Rice
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…
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FDA Issues Draft Guidance About Mandatory Food Recalls
The U.S. Food and Drug Administration (FDA) has issued draft guidance about the implementation of mandatory food recall provisions under the Food Safety Modernization Act (FMSA).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…
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Mad Cow Disease Risk on the Agenda of Upcoming TSE Advisory Committee Meeting
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…
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Putative Class Action Targets Kind LLC’s “Healthy” Claim
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.,…
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CSPI Challenges GRAS Approval Process
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…
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FWW Report Examines “Controversial” Animal Drugs
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…