The U.S. Food and Drug Administration (FDA) plans to set requirements for fermented and hydrolyzed foods or those containing fermented or hydrolyzed ingredients and carry the “gluten-free” claim. The proposed rule would apply to foods such as sauerkraut, yogurt, pickles, cheese, green olives, vinegar, and FDA-regulated beers. Intended to address the uncertainty of interpreting test methods in terms of intact gluten, the finalized rule would mandate manufacturers to maintain records demonstrating: (i) “the food meets the requirements of the gluten-free labeling final rule prior to fermentation or hydrolysis; (ii) “the manufacturer has adequately evaluated its process for any potential gluten cross-contact”; and (iii) “where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.” The agency also intends to evaluate the compliance of distilled foods by using scientifically valid methods to determine the absence…
Category Archives Food and Drug Administration
In conjunction with its decision to approve the first genetically engineered (GE) animal for human consumption, the U.S. Food and Drug Administration (FDA) has published final labeling guidance for foods derived from GE crops and draft labeling guidance for GE salmon. Titled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants,” the final guidance document seeks to assist “food and feed manufacturers that wish to voluntarily label their plant-derived food products or ingredients (for humans or for animals) as having been made with or without bioengineering.” In addition, the agency’s draft labeling guidance—“Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon”—describes the preferred labeling terms for products marketed as containing or avoiding transgenic salmon. Emphasizing that such labeling should be “truthful and not misleading,” the agency recommends that manufacturers wishing to identify their products as not derived from GE ingredients use…
The U.S. Food and Drug Administration (FDA) has released its determination that genetically engineered (GE) salmon produced by AquaBounty Technologies, Inc., is as safe to eat as conventional salmon and will have little effect on the environment. Containing genes from Pacific Chinook salmon and ocean pout that accelerate growth and maturation, AquAdvantage® salmon is the first GE animal approved for human consumption. After spending more than a decade reviewing data on food safety and environmental impacts, the agency apparently concluded that (i) “the inserted genes remained stable over several generations of fish,” (ii) “food from the GE salmon is safe to eat by humans and animals,” (iii) “the genetic engineering is safe for the fish,” and (iv) “the salmon meets the sponsor’s claim about faster growth.” FDA also found that the multiple containment measures taken by land-based production facilities are sufficient to prevent the fish from mixing with wild populations.…
The U.S. Department of Justice (DOJ) and U.S. Food and Drug Administration (FDA) have announced the latest developments in civil and criminal actions taken against 117 dietary supplement manufacturers and distributors as the result of a year-long investigation into allegedly tainted products. According to a November 17, 2015, DOJ press release, an 11-count indictment alleges that weight-loss and workout supplement manufacturer USPlabs LLC “engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients.” The indictment claims the products in question were sold to retailers across the nation, with USPlabs asserting that it used natural plant extracts “when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.” “The joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements and products falsely…
U.S. Sen. Chuck Schumer (D-N.Y.) is urging the U.S. Food and Drug Administration (FDA) to investigate the increased availability of caffeinated foods in light of a new peanut butter product containing 150 mg of caffeine per 2-tablespoon serving. “The FDA should take immediate action and investigate whether this caffeine product should be pulled from shelves,” Schumer said. “To think that peanut butter, one of the snacks most closely associated with children, might have to be stored in the medicine cabinet as opposed to the kitchen cabinet should serve as a jolt to the FDA.” See Press Release of Sen. Chuck Schumer, November 8, 2015. According to the manufacturer’s website, STEEM Caffeinated Peanut Butter contains no artificial sweeteners and “as much caffeine as two cups of coffee, so stick with the normal serving suggestions for the best effect.” The site cautions that feeding the product to domestic animals could “lead to…
Citing citizen petition and federal court requests for the agency to define “natural” for use in food labeling and determine if food products containing genetically engineered ingredients and high-fructose corn syrup may be labeled as “natural,” the U.S. Food and Drug Administration (FDA) is soliciting information and comments about use of the term in the labeling of human food products. More specifically, FDA seeks responses to questions that include the following: (i) Should the agency define natural through rulemaking? (ii) Should the agency prohibit use of the term in food labeling? (iii) If the agency defines natural, what foods should be permitted to bear the term? (iv) Should certain production practices, e.g., salting, irradiating, be considered in defining the term? (v) Should natural be applied only to “unprocessed” foods? (vi) Should the way an ingredient is produced or sourced affect whether a product containing that ingredient be labeled natural? and…
The U.S. Food and Drug Administration (FDA) has filed three final rules under the Food Safety Modernization Act (FSMA) on produce safety, foreign supplier verification programs (FSVPs) and accredited third-party certification, all slated for publication in the November 27, 2015, edition of the Federal Register. The agency will also hold a webinar series to discuss the new rules, which are intended to “establish enforceable safety standards for the production and harvesting of produce on farms and make importers accountable for the safety of the food they bring into the U.S.” The produce safety rule addresses, among other things, (i) the quality and testing of agricultural water, (ii) biological soil amendments such as raw manure and stabilized compost, (iii) food safety requirements for sprouts, (iv) the management of domesticated and wild animals, (v) health, hygiene and worker training, and (vi) sanitation standards for equipment, tools and buildings. FDA also describes hazard…
A German court has reportedly ordered the city of Hamburg to compensate a Spanish vegetable grower falsely linked to a 2011 E. coli outbreak that sickened more than 4,000 people in 16 countries. Vegetable cooperative Frunet asserted that it suffered €2.3 million in damages as a result of its incorrect identification as the source of the outbreak, which was later traced to fenugreek sprouts. The amount of the award has not been confirmed. See Think Spain, October 25, 2015. Meanwhile, the U.S. Court of Appeals for the Federal Circuit has affirmed a lower court’s decision that the government does not owe tomato growers compensation after the U.S. Food and Drug Administration (FDA) publicly attributed a 2008 Salmonella outbreak to red tomatoes, then later traced it to jalapeno and serrano peppers. DiMare Fresh, Inc. v. U.S., No. 15-5006 (Fed. Cir., order entered October 28, 2015). “The problem with the Tomato Producers’ contention…
The Center for Science in the Public Interest (CSPI) has filed a lawsuit against the U.S. Food and Drug Administration (FDA) to compel the agency to act on the advocacy group’s 2005 citizen petition requesting regulations about the use of salt as a food additive. Ctr. for Sci. in Pub. Interest v. FDA, No. 15-1651 (D.D.C., filed October 8, 2015). The petition called for FDA to revoke salt’s status as generally recognized as safe, amend prior approvals of salt use, require food manufacturers to reduce sodium levels in processed foods, and mandate labeling messages about the health effects of salt in foods containing more than half an ounce of the substance. The complaint alleges that while “[n]early all Americans consume more sodium than is safe,” “[c]onsumers can exert relatively little control over their sodium intake by adjusting discretionary use of salt” because such use amounts to only 5 to 10…
Three federal agencies are convening an October 30, 2015, public meeting in Silver Spring, Maryland, to discuss a July 2015 memorandum issued by the Executive Office of the President (EOP) directing the agencies to clarify their roles in the oversight of biotechnology products, develop long-term regulatory strategies and commission an independent study of the biotech landscape. The EOP memo defines biotechnology products as those “developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes.” The meeting will include presentations by representatives of the Department of Agriculture, Environmental Protection Agency and Food and Drug Administration (FDA) about each agency’s current approach to biotech product regulation. Information about registration, oral presentations and viewing the meeting via live webcast is available on FDA’s website. See Federal Register, October 16, 2015. Issue 581
