Category Archives Food and Drug Administration

Following a petition from several advocacy groups, the U.S. Food and Drug Administration (FDA) has deauthorized the use of seven synthetic substances used as flavoring in foods. The agency found that the advocacy groups provided data demonstrating that six ingredients cause cancer in animals—benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone and pyridine—and removed styrene from its food additives list, finding that it has been permanently abandoned in that use. In addition, FDA has banned the use of benzophenone as "a plasticizer in rubber articles intended for repeated use in contact with food." The rule took effect October 9, 2018.

The U.S. Food and Drug Administration (FDA) has solicited public input on questions related to plant-based substitutes for dairy products such as almond or soy milk. The agency's request for information (RFI) seeks responses on three points: "How do you use plant-based products?" "What is your understanding of dairy terms like milk, yogurt and cheese when they are used to label plant-based products?" "Do you understand the nutritional characteristics of plant-based products? Do you know how they’re different from each other? Do you know how their nutritional qualities compare with dairy products?" "The RFI opened today is an important step in our efforts to take a look at how we have been applying the Food Drug and Cosmetic Act with respect to food names and our existing standards of identity," FDA Commissioner Scott Gottlieb said in a statement. "The comments we receive will help inform the development of draft guidance…

The U.S. Food and Drug Administration (FDA) has announced the results of its annual Pesticide Residue Monitoring Program. From samples collected between October 1, 2015, and September 30, 2016, the agency analyzed 7,413 samples and reportedly found that more than 99 percent of domestic and 90 percent of imported foods complied with federal standards. FDA also examined samples of corn, soybeans, milk and eggs and found zero samples that violated federal limits. FDA Commissioner Scott Gottlieb said in a statement, "Like other recent reports, the results show that overall levels of pesticide chemical residues are below the Environmental Protection Agency’s tolerances, and therefore don’t pose a risk to consumers.”

The U.S. Food and Drug Administration (FDA) has issued draft guidance on the release of retailer information during the food-recall process. The guidance indicates when the agency may find that identifying retailers is necessary during Class I recalls—"recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals"—as well as a limited number of Class II recalls associated with foodborne illness outbreaks. "Assisting food producers in having effective recall practices in place, as well as taking immediate action to address unsafe products, are high priorities of mine," FDA Commissioner Scott Gottlieb said in a statement. "Our recall authorities – and how we deploy them – are a cornerstone of our vital consumer protection mission."

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement on testing for Cyclospora as a foodborne pathogen. The statement noted that the testing methods allowed the agency to identify Cyclospora in cilantro, marking the first time it found the parasite in domestically grown produce. "We must continue to put in place science-based measures to prevent microbial contamination from occurring, and work with our state and foreign partners to implement the Produce Safety Rule," Gottlieb stated. "We’ve been working closely with the National Association of State Departments of Agriculture and our state partners to, among other things, train federal and state regulators who will conduct inspections slated to begin next spring, develop inventories of farms that are covered by the rule, put in place the Produce Safety Network to support the states and their farming communities regionally, conduct On Farm Readiness Reviews to help farmers assess their…

The U.S. Food and Drug Administration (FDA) has published Commissioner Scott Gottlieb's September 14, 2018, remarks delivered at the Pew Charitable Trusts on the issue of antimicrobial resistance, including the effects of antibiotics in animals raised for food production. Gottlieb indicated that the agency will release "a draft strategy, likely as a new guidance for industry, by the end of fiscal year 2020" to advise companies on "ensuring that medically important antimicrobials are labeled with appropriately defined durations of use." In addition, FDA's Science Board will hold a public meeting on October 22, 2018, to hear the Center for Veterinary Medicine's response to the board's recommendations on the National Antibiotic Resistance Monitoring System. The board will also discuss "potential hazards and nutritional considerations in the production of food derived from animal cell culture technologies."

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement providing an update on how mandated added-sugar labeling will affect honey and maple syrup. "We recognized that this new labeling information on 'packaged as such' products may inadvertently lead consumers to think their pure products, such as a jar of honey or maple syrup, may actually contain added table sugar or corn syrup because there are 'added sugars' listed on the label," Gottlieb notes. FDA previously proposed the use of an additional disclosure for honey and maple syrup products, but "the more than 3,000 comments we received on the draft guidance indicate that there are further opportunities to update our proposed approach," according to the press release. Gottlieb indicated that final guidance will be released in 2019. "This guidance will provide a path forward for pure, single-ingredient 'packaged as such' products that does not involve the standard 'added…

The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have announced a joint public meeting to discuss "the use of cell culture technology to develop products derived from livestock and poultry." The meeting, which will be held October 23-24, 2018, will focus on "the potential hazards, oversight considerations, and labeling" of the product category. Following a conference hosted by the Good Food Institute, cell-based meat brand representatives reportedly agreed to "abandon[] the term 'clean meat' in favor of cell-based meat." "We discussed the pros and cons of the term 'clean meat,' and decided to shift our label to 'cell-based meat,'" a conference attendee reportedly told Food Navigator. "Traditional meat companies can be our biggest ally if they want to work with us. We can help them transition from industrial animal agriculture to cell-based meat. Cell-based meat is a better label to bring them on board."

Following his related statements at a conference, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has announced that the agency will review the standardized identities of dairy products and products marketed as their substitutes, including beverages made from almonds, rice or soy. The announcement suggests that allowing the plant-based substitutes to be labeled as “milk” has caused confusion among consumers and led to detrimental effects on children. “We’re going to have an active public process for reviewing our standard and how consumers understand the use of terms like milk on both animal-derived and plant-based products," Gottlieb said in the announcement. "We want to see if the nutritional characteristics and other differences between these products are well-understood by consumers when making dietary choices for themselves and their families. We must better understand if consumers are being misled as a result of the way the term milk is being applied and…

At a speaking engagement, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly expressed that the agency’s standards of identity for milk have not been enforced. According to the standard of identity, milk is “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows,” a definition that does not include non-dairy beverages produced from almonds, soy, rice or coconuts that are labeled as milk. Admitting that “an almond doesn’t lactate,” Gottlieb reportedly indicated that FDA will begin collecting public comments before determining its approach to the issue.

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