Category Archives Issue 543

A California federal court has rejected in part and granted in part Total Sweeteners Inc.’s motion for summary judgment in a case alleging that the molasses supplier sold American Licorice Co. shipments tainted with lead that American Licorice then used to create Red Vines black licorice candy, resulting in a costly recall. Am. Licorice Co. v. Total Sweeteners Inc., No. 13-1929 (N.D. Cal., order entered October 22, 2014). Additional details about the case appear in Issue 494 of this Update. American Licorice argued that, under the sales contract, Total Sweeteners was obliged to provide molasses that complied with state and federal regulations; Total Sweeteners asserted that American Licorice knew that molasses has some naturally occurring lead and should have tested for it upon receipt. The court focused on the contract, agreeing with Total Sweeteners that the sales contract between the parties, and not a subsequent purchase order with terms favorable…

The World Health Organization (WHO) has issued a technical report from a joint Food and Agriculture Organization/WHO Expert Committee tasked with evaluating the safety of certain veterinary drugs and recommending maximum residue limits (MRLs) in food. Among other things, the report addresses toxicological and residue data on various anthelminthic, antiparasitic, antifungal, and antibacterial agents and attendant MRLs in minor species, honey and fish.   Issue 543

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 Environment Protection Agency (EPA) has updated its Toxic Substances Control Act (TSCA) Work Plan for Chemical Assessments to include bisphenol A (BPA), seven phthalates and 15 other substances. Designed to help the Office of Pollution Prevention and Toxics identify chemicals with “the highest potential for exposure and hazard,” the TSCA Work Plan in 2012 flagged 83 chemicals as part of an ongoing initiative to expedite assessments for substances believed to have reproductive, developmental or neurotoxic effects, as well as those that are “probable or known carcinogens” or “persistent, bioaccumulative and toxic.” The plan also targets substances used in children’s products and those that have been detected in biomonitoring programs. This latest update to the TSCA Work Plan removes 15 chemicals and adds 23 new ones, bringing the total list to 90 chemicals. In addition to BPA, the chemicals added to the updated list include dibutyl phthalate, butyl benzyl phthalate, di-(2-ethylhexyl) phthalate, di-n-octyl…

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…

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