Category Archives Food and Drug Administration

Rep. Jerry McNerney (D-Calif.), in partnership with the Natural Products Association, has reportedly filed an amendment to the House Agriculture appropriations bill that would give the U.S. Food and Drug Administration (FDA) funding to undertake the process to identify a safe daily intake level of cannabidiol (CBD). “Since the passage of the 2018 Farm Act – which eliminated hemp from the definition of marijuana under the Controlled Substances Act – we’ve seen a significant increase in the production and sales of CBD products,” said McNerney in a June 18, 2019, press release. “With more and more CBD appearing on supermarket shelves across the country, it’s time for American consumers to have accurate information on CBD and for producers to be properly regulated to make the marketplace safe and reliable.” FDA has also announced the extension of the comment period for the public hearing intended to "obtain scientific data and information…

The U.S. Food and Drug Administration (FDA) has issued a statement on per- and polyfluoroalkyl substances (PFAS) in food following a presentation published in the media that indicated the agency found the substances in meat, fish and chocolate. "Overall, our findings did not detect PFAS in the vast majority of the foods tested," the statement reads. "In addition, based on the best available current science, the FDA does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling. These data give our scientists a benchmark to use as we continue our critical work studying this emerging area of science."

The U.S. Food and Drug Administration has finalized guidance on labeling for added sugars in single-ingredient packages of "pure honey, pure maple syrup, and other pure sugars and syrups, which are not required to bear the words 'Includes Xg Added Sugars' but must still include the percent Daily Value (DV) for added sugars on their labels." The agency also indicated its intention "to exercise enforcement discretion with respect to the use of truthful and not misleading statements on single-ingredient packages and/or containers."

The U.S. Food and Drug Administration (FDA) has indicated that it will seek public comment on a proposal that would allow the accreditation of third-party certification bodies "to conduct food safety audits of eligible foreign food facilities, and issue food and facility certifications, pursuant to the FDA Food Safety Modernization Act." The notice responds to a number of comments received following a comment period on the proposed collection of information, including a note that the third-party certification system could help the government "prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply" because current resources are limited.

The U.S. Department of Agriculture and Health and Human Services have announced meetings to hear public comments on the 2020 dietary guidelines revisions. The 2020 Dietary Guidelines Advisory Committee will allow three-minute pre-registered comments from the public at its meetings on July 11, 2019, and January 25, 2020, and registration for the July meeting closes at 5:00 p.m. on July 1.

The U.S. Food and Drug Administration (FDA) has sent a letter to food and beverage manufacturers recommending that they primarily use "Best If Used By" on their packages to help consumers who may be confused by the use of the phrase "Sell By." The letter explains that the Grocery Manufacturers Association and Food Marketing Institute have recommended that food manufacturers use the distinguishing phrases "Best If Used By"—for foods that may decline in quality after a specific date but remain safe to eat—and "Use By," which should appear on the label of perishable foods that should be discarded after a specific date for safety reasons. "As approximately 80% of the foods in the US are regulated by the FDA, we would like to inform our regulated food industries that FDA strongly supports industry’s voluntary industrywide efforts to use the 'Best if Used By' introductory phrase when choosing to include a…

The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry on the use of "potassium chloride salt" on food labels as an acceptable alternative to the use of the common or usual name "potassium chloride." The guidance indicates that the agency recognizes that food manufacturers "wishing to reduce sodium chloride in their products sometimes use substitute ingredients that provide similar taste and technical functions of sodium chloride in foods," including potassium chloride, which is generally recognized as safe for use as a flavor enhancer, flavoring agent, nutrient supplement, pH control agent, stabilizer and thickener. Comments on the draft guidance will be accepted until July 19, 2019.

The U.S. Food and Drug Administration (FDA) has issued draft guidance allowing food manufacturers to exclude allulose when calculating the amount of added sugars a product contains. Allulose is "approximately 70 percent as sweet as sucrose," according to a comment FDA received, and "does not have the metabolic properties of fructose or other sugars and does not contribute calories or raise blood sugar levels like other sugars." FDA has proposed to "exercise enforcement discretion for the exclusion of allulose from the amount of 'Total Sugars' and 'Added Sugars' declared on the label and the use of a general factor of 0.4 calories per gram for allulose when determining 'Calories' on the Nutrition and Supplement Facts labels pending review of the issues in a rulemaking." Comments on the draft guidance will be accepted until June 17, 2019.

The U.S. Food and Drug Administration (FDA) has issued draft guidance on initiating voluntary recalls of food and other agency-regulated products. The guidance discusses (i) "what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures"; (ii) "preparations firm in the distribution channel should consider making to ensure timely responses to a recall communication"; and (iii) "how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by the FDA." Comments on the draft guidance will be accepted until June 24, 2019.

The U.S. Food and Drug Administration has announced that inspections for compliance with a rule aiming to mitigate the risk of intentional adulteration (IA) will begin in March 2020. The rule, which "is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health," requires "the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration." "To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020," the agency announced.

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