• Regulatory NewsRegulatory News

    FDA reaffirms that CBD products can’t be marketed as dietary supplements

    The US Food and Drug Administration (FDA) has objected to New Dietary Ingredient (NDI) notifications submitted by two developers of full-spectrum hemp extract products, telling the companies an earlier decision by the agency to consider cannabidiol (CBD) as a drug means it won’t consider their applications to sell the products as dietary supplements.   Writing to Irwin Naturals, FDA said the company’s product, NDI 1199, contains CBD, which is an active ingredient in Ep...
  • Feature ArticlesFeature Articles

    June’s Regulatory Focus: Nutrition in health and disease management, and the gut microbiome

    This issue marks the 6th annual RAPS series on nutrition in health and disease management, and the gut microbiome, in which global experts write about food, nutrition, and dietary supplements from regulatory, trade, marketing, and legal perspectives. In keeping with the series, articles in the current issue examine US Food and Drug Administration (FDA) regulatory guidance and requirements, especially regarding dietary supplements, bioengineered products, probiotics, and CO...
  • Feature ArticlesFeature Articles

    Global regulatory trends in CBD use in food and food supplements

    This article examines the regulatory trends for using cannabidiol (CBD) as an ingredient in foods and food supplements and provides guidance for companies to interpret current regulation and predict its future direction. The author discusses navigating current regulatory complexity to realize commercial opportunities and outlines the challenges and opportunities for bringing food and food supplement products containing CBD to markets around the world.   Introduction ...
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    FDA warns Cannafyl for CBD claims

    The US Food and Drug Administration has warned a company marketing cannabidiol products for its advertising claims about the drops and salves it markets and sells online.   Scottsdale, AZ-based Cannafyl made claims that cannabidiol (CBD) “helps manage cancer growth,” in an October 2020 blog post on the Cannafyl website entitled “CBD for Breast Cancer,” according to FDA’s Center for Drug Evaluation and Research (CDER). In its warning letter, CDER also cites claims in th...
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    FDA Warns Drug Manufacturers as FTC Warns CBD Advertisers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to South Korea-based drug manufacturer Enprani Co. and China-based drug manufacturer Hangzhou Badi Daily Use Chemical Company. Meanwhile, the Federal Trade Commission (FTC) on Tuesday said it sent warning letters to three unnamed companies for illegal advertising of products containing cannabidiol (CBD). The letter for Enprani, which follows a five-day inspection last March, shows how...
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    UK’s MHRA: Products Containing Cannabis Extract are Medicines

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently come to the decision that products containing cannabidiol (CBD) are a medicine, following a regulatory review of such products. “We have come to the opinion that products containing cannabidiol (CBD) are a medicine. Products for therapeutic use must have a medicines’ licence before they can be legally sold, supplied or advertised in the UK. Products will have to meet safety, quality a...