The Food and Drug Administration (FDA) has published draft guidance titled “Frequently Asked Questions About Medical Foods; Second Edition” that provides additional information about the definition, labeling and availability of medical foods—“foods formulated to be consumed or administered orally or enterally under the supervision of a physician.” The first edition of this guidance was issued in May 2007. Comments will be accepted until October 15, 2013. See Federal Register, August 13, 2013.
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has issued a final rule providing “for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum.” According to FDA, “Spirulina is a blue-green filamentous cyanobacteria that occurs naturally in freshwater and marine habits.” Its extract primarily contains “the water soluble components of spirulina, namely phycocyanins and other proteins, polysaccharides, lipids, and minor amounts of components such as vitamins, minerals, and moisture.” FDA has also determined that “there is no need for a specific upper limit for the color additive or phycocyanin content,” although the extract must abide by limits for lead, arsenic and mercury, in addition to testing negative for the microcystin toxin, “which is produced by some species of cyanobacteria that could be potentially present in the water where A. platensis is grown and harvested.”…
A recent study published in JAMA Internal Medicine has faulted the Food and Drug Administration’s (FDA’s) process for declaring food additives “generally recognized as safe” (GRAS), citing alleged financial conflicts of interest among those chosen by companies to verify the safety of new additives. Thomas Neltner, et al., “Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance,” JAMA Internal Medicine, August 2013. Led by Thomas Neltner, director of the Pew Health Group’s Food Additive Project, researchers used the Institute of Medicine’s conflict of interest criteria to analyze “451 GRAS notifications voluntarily submitted to FDA between 1997 and 2012.” In particular, they sought to determine (i) “the likelihood that a decision by an individual making a [GRAS] determination would be unduly influenced by the financial interests of a manufacturer of an additive,” and (ii) “the seriousness of possible harm if a GRAS…
The U.S. Food and Drug Administration (FDA) has filed a motion for reconsideration or stay of a court order establishing rulemaking deadlines under the Food Safety Modernization Act. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., Oakland Div., motion filed July 19, 2013). More information about the litigation appears in Issues 481, 487 and 489 of this Update. Scheduled to be heard on August 28, 2013, the motion contends that two of the seven rulemakings at issue, the sanitary transport rule and the intentional adulteration rule, pose challenges that preclude their issuance by the court’s deadline. Requesting that the court reconsider its order largely on the basis of arguments already rejected, the agency also asks the court to stay the order pending the Solicitor General’s determination whether to authorize an appeal and, if an appeal is authorized, while the appeal is pending.
The U.S Food and Drug Administration (FDA) has announced a public meeting of the Food Advisory Committee on September 23-24, 2013, in Silver Spring, Maryland. The committee plans to discuss detection signals for chemical hazards in foods, dietary supplements and cosmetics, and review information sources and chemical hazard data. FDA will accept comments until September 16, 2013. See Federal Register, July 23, 2013.
The U.S. Food and Drug Administration (FDA) has proposed two rules under the Food Safety Modernization Act (FSMA) for verifying foreign suppliers and accrediting third-party auditors. Part of the agency’s effort “to ensure that imported food meets the same safety standards as food produced in the United States,” the proposed rules would (i) require importers to verify “that their foreign suppliers are implementing modern, prevention-oriented food safety practices,” and (ii) “strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains.” In particular, the rules establishing foreign supplier verification programs would hold U.S. importers responsible for ensuring that human and animal food produced abroad meets the safety standards set forth in the Federal Food, Drug, and Cosmetic Act and is neither adulterated nor misbranded “with respect to food allergen labeling.” In addition, FDA has proposed creating…
The U.S. Food and Drug Administration (FDA) has issued a final rule defining the term “gluten-free” for voluntary food labeling. Among other things, the rule defines “gluten-free” to mean that a food does not contain (i) an ingredient that is a gluten-containing grain (e.g., spelt wheat); (ii) an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or (iii) an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch). In addition, a food must contain less than 20 parts per million of gluten to use the term “gluten-free” on its label. According to FDA, a food that bears the claim “no gluten,” “free of gluten” or “without gluten” on its label and fails to meet the requirements for a “gluten-free” claim will be deemed misbranded. The rule will take effect 30 days after its publication in…
A federal court in California has dismissed without prejudice a putative class action alleging that Wholesoy & Co. misleads consumers by (i) listing “organic evaporated cane juice” instead of “sugar” or “dried cane syrup” as an ingredient on its soy yogurt products in violation of Food and Drug Administration (FDA) labeling rules, and (ii) marketing its soy product as yogurt because it fails to comply with FDA’s standard of identity for “yogurt.” Hood v. Wholesoy & Co., No. 12-5550 (N.D. Cal., decided July 12, 2013). The court agreed with the company that the complaint must be dismissed under the primary jurisdiction doctrine because its resolution would require the court to decide an issue committed to the agency’s expertise “without a clear indication of how FDA would view the issue.” Specifically, the court found that the evaporated cane juice guidance document on which the plaintiff relied is expressly “not a ‘legally…
The Food and Drug Administration (FDA) has issued a request for comments, scientific data and information to use in risk assessment of human salmonellosis associated with the consumption of tree nuts, including almonds, cashews, pistachios, pine nuts, Brazil nuts, macadamia nuts, and walnuts. The risk assessment seeks to quantify the public health risk associated with eating tree nuts potentially contaminated with Salmonella and evaluate the impact of interventions to prevent contamination with the bacterium or to reduce contamination levels. FDA said an assessment is necessary in light of “outbreaks of human salmonellosis linked to tree nuts during the past decade, by product recalls, and by Salmonella isolation from tree nuts during surveys.” Comments will be accepted until October 16, 2013. See Federal Register, July 18, 2013.
The Food and Drug Administration (FDA) has published new guidance on Salmonella-contaminated food for animals. Titled “Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals” (CPG), the guidance finalizes the draft CPG that was announced in August 2010 and includes the following changes: (i) the title has changed from “Salmonella in Animal Feed” to “Salmonella in Food for Animals” to clarify that it covers all animal food, including pet food and animal feed, and (ii) the term “direct human contact animal feed” has been replaced with the term “pet food” and includes treats and chews. FDA has also announced (i) the removal of 21 CFR 500.35 “Animal feeds contaminated with Salmonella microorganisms,” and (ii) the withdrawal of “Compliance Policy Guide Sec. 690.700 Salmonella Contamination of Dry Dog Food.” See Federal Register, July 16, 2013.
