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…
Tag Archives FDA
On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a widely anticipated public hearing with stakeholders on cannabis and cannabis-derived compounds to gain insights on product safety and a potential regulatory framework for products containing such substances. The hearing focused on cannabidiol (CBD)—a popular but controversial compound that has been added to products ranging from tinctures and lotions to sodas and ice cream. Interest in the product was spurred by the passage of the 2018 Farm Bill, which removed hemp (cannabis plants with less than 0.3% THC content) from the Controlled Substances Act. The Farm Bill also complicated FDA’s role in regulating CBD because although the substance was de-scheduled by Congress, the Agency still regulates it as a drug—meaning that any consumer product with CBD is technically a misbranded drug in violation of FDA rules. While the Agency has taken limited actions against companies using CBD as…
The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry on the use of "potassium chloride salt" on food labels as an acceptable alternative to the use of the common or usual name "potassium chloride."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.
The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for cannabis and cannabidiol (CBD) products. Specifically, this includes a public hearing, an agency working group, question-and-answer updates and the possibility of enforcement actions. A public hearing on May 31, 2019, aims to obtain “scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Electronic or written comments will be accepted until July 2, 2019. FDA is seeking comments, data and information related to (i) what levels of cannabis cause safety concerns; (ii) how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, cannabis; (iii) how cannabis interacts with other substances; and (iv) standardized definitions for cannabis-related ingredients, supply chain quality control, effective marketing and labeling of…
The U.S. Food and Drug Administration has announced an April 25, 2019, public webinar about "genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits." The webinar will focus on "current scientific evidence, promising uses of this technology in animals, and the potential risks." FDA intends the webinar to help "those using genome editing to develop animals with genomic alterations," but registration is open to the public.
The U.S. Food and Drug Administration (FDA) has deactivated an import alert that prevented the introduction of genetically engineered (GE) salmon into interstate commerce. The agency's statement indicates that it placed the ban in 2016 with the intention of lifting it when standards for labeling GE food were finalized. With the implementation of the National Bioengineered Food Disclosure Standard in late 2018, the authority to regulate GE food shifted to the U.S. Department of Agriculture (USDA), according to the statement, so the import ban deactivation will remove barriers for USDA regulation. "With the deactivation of the import alert, AquAdvantage Salmon eggs can now be imported to the company’s contained grow-out facility in Indiana to be raised into salmon for food. As was determined during the FDA’s 2015 review, this fish is safe to eat, the genetic construct added to the fish’s genome is safe for the animal, and the manufacturer’s…
Kind LLC has submitted a citizen petition urging the U.S. Food and Drug Administration (FDA) to require disclosure of added sugar and trans fat on food packaging and remove the required disclosures for total fat and cholesterol. In addition, the petition recommends that FDA "[r]evise its nutrient content claim regulations to only allow a food to bear a nutrient content claim highlighting the presence or absence of a nutrient if the food contains a meaningful amount of at least one health-promoting food, such as: vegetables, fruits (especially whole fruits), whole grains, legumes, nuts, and seeds, which are recommended in the most recent Dietary Guidelines for Americans."
