The U.S. Food and Drug Administration (FDA) has announced a public meeting to discuss the agency's "effort to modernize food standards of identity (SOI) and provide information about changes we could make to existing SOI, particularly changes that could be made across categories of standardized foods (i.e., horizontal changes), to provide flexibility for the development of healthier foods." The meeting will be held September 27, 2019, and comments on the subject will be accepted until November 12.
Category Archives Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has issued the first warning letter enforcing the Food Safety Modernization Act (FSMA) Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. The letter targeted a company importing tahini that was recalled after purportedly causing a Salmonella outbreak. "Moving forward, the FDA will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk," the agency's announcement stated.
The U.S. Food and Drug Administration's Office of Nutrition and Food Labeling has released guidance providing "step-by-step instructions to manufacturers of retail food products marketed in the United States on how they may convert the previous units of measure for certain nutrients to the new units in the updated Nutrition Facts label." The guidance also "provides information that can help manufacturers understand and comply with relevant labeling requirements," according to the agency's announcement.
Illinois has passed a law requiring businesses to indicate on food labels whether a product contains sesame. The amended law deems a food misbranded if "it contains sesame, is offered for sale in package form but not for immediate consumption, and the label does not include sesame." The state representative who sponsored the legislation told the NPR affiliate that his daughter is allergic to sesame and has received incorrect answers when inquiring about the ingredient at restaurants. “If they see us do it, the hope is that everyone does it,” he reportedly told WILL. “I hope that the [U.S. Food and Drug Administration (FDA)] and other states will follow suit." FDA and the U.K. Food Standards Agency have opened investigations into the prevalence of sesame as an allergen in prepared food products, while Canada, the European Union, Australia and Israel have reportedly enacted regulations requiring sesame labeling.
The U.S. Food and Drug Administration (FDA) has announced that soy leghemoglobin has been approved for use "as a color additive in ground beef analogue products" following a petition submitted by Impossible Foods. The announcement notes that the agency previously found soy leghemoglobin to be generally recognized as safe as a flavor additive. "FDA concurs with the petitioner that the genetic modifications made to generate the non-toxigenic and non-pathogenic production strain are well-characterized and the production process conforms to good manufacturing practice," the announcement states. "In addition to specification limits for lead, arsenic, mercury, and cadmium, we are requiring a specification for the minimum purity of soy leghemoglobin protein as a percent of the total protein in the color additive." The rule takes effect September 4, 2019, and objections can be filed until September 3.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Curaleaf Inc. for "illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer's disease, opioid withdrawal, pain and pet anxiety." FDA cites the company's website and social media accounts to assert that Curaleaf's marketing establishes its products—including "Bido CBD for Pets"—as drugs or animal drugs because the products are portrayed as able to help alleviate anxiety and fear, among other purported benefits. The agency also indicated that it will update the public on its progress towards creating a CBD regulatory framework by fall 2019. "We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related…
A group of 38 state attorneys general have submitted a letter to the U.S. Food and Drug Administration (FDA) in response to the agency's call for comments on possible regulatory approaches for cannabis and cannabis-derived products such as cannabidiol (CBD). "As the primary enforcers of our respective states' consumer protection laws, we offer a unique perspective as to the new legalized market of certain cannabis and cannabis-derived compounds, including CBD products," the letter states. "A crucial element of FDA regulation and oversight should be an on-going assessment of the potential risks or benefits of these products, particularly for specific populations such as pregnant women, adolescents and children, and the elderly. How these products interact with other dietary or pharmaceutical products should be included in this assessment. It is also important that companies not mislead consumers. Scientific and medical data from the FDA would assist in meaningful enforcement of advertising laws…
The U.S. Food and Drug Administration (FDA) has issued guidance revising advice for pregnant women about safe fish consumption. “Advice About Eating Fish: For Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children” includes "a statement that eating fish when pregnant or breastfeeding can provide health benefits and states that fish and other protein-rich foods have nutrients that can help children's growth and development. The revisions also include a statement that, as part of a healthy eating pattern, eating fish may offer heart health benefits and lower the risk of obesity. The revised advice also makes clear that many types of fish are both nutritious and lower in mercury." FDA will accept comments until September 9, 2019, about suggested additional target populations for the advice, suggestions for effective means to distribute the advice and other information that may be useful to include.
The U.S. Food and Drug Administration (FDA) has issued an update for consumers explaining its investigations into cannabis and cannabis-derived compounds, including cannabidiol (CBD). The agency indicates that it is "working to learn more about the safety of CBD and CBD products," specifically: (i) "[t]he effects CBD could cause in the body, such as toxicity to the liver, when someone ingests CBD regularly over a long period of time"; (ii) "[t]he cumulative exposure to CBD if people access it across a broad range of consumer products"; (iii) "[t]he effects of CBD on special populations (e.g., the elderly, children, adolescents, pregnant and lactating women) or types of animals (e.g., species, breed, or class)"; and (iv) "[t]he safety of CBD use in animals (e.g., species, breed, or class) including pets." FDA also advises that "unapproved CBD drug products have not been subject to FDA review as part of the drug approval process,…
The U.S. Food and Drug Administration (FDA) has announced that it will not object to claims that "consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease." FDA's research on the claim included reviewing more than 700 studies and 22 public comments submitted on the subject. The approved qualified health claims include that EPA and DHA "may help lower blood pressure" and "reduce the risk for hypertension" but also reference that "FDA has concluded that the evidence is inconsistent and inconclusive."
