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…
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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 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."
U.S. Sen. Dick Durbin (D-Ill.) and Rep. Rosa DeLauro (D-Conn.) have introduced the Safe Food Act of 2019, "which would create a single, independent food safety agency." In addition, the proposed law would "[r]equire full food traceability to better identify sources of outbreaks" and "[s]trengthen oversight of foreign food facilities and improve food import inspections." The proposal echoes similar legislation the pair proposed in 1999.
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.
