- Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies such as the Food and Drug Administration (FDA) must obtain approval from the Office of Management and Budget Review (OMB)
New Citizens Petition Requests FDA Status for Hemp-Derived CBD in Dietary Supplements
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- We reported on a November 14, 2019 citizen petition submitted to FDA by the Consumer Healthcare Products Associated (CHPA) requesting that the agency issue regulations to establish a clear pathway
9th Circuit Judge Asks What Amount of Added Sugar in a Product Makes the Product Unhealthy, a Question About Which Other Courts Have Ruled There is a Material Issue of Fact in Allowing Similar Cases to Proceed
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9th Circ. Judge Doubts General Mills False Label Claims (subscription to Law360 required)
- Proposed class action lawsuits against Kellogg, Post, and General Mills, with a common lead plaintiff in the
CBD Brands Commit to Sponsor Observational Research to Evaluate the Impact of Daily CBD Use on the Liver Function of Healthy Adults
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- A group of seven CBD brands (Boulder Botanicals & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway) have committed to collectively sponsor ValidCare (a
North American Olive Oil Association Submits Citizen Petition to FDA Asking for Standard of Identity for Olive Oil and Olive-Pomace Oil
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- In late May 2020, the North American Olive Oil Association submitted a citizen petition to FDA, asking the Agency to adopt science-based, enforceable standards for olive oil. In its petition
FDA Describes “Substantial Progress” Without Providing Any Specific Details on Planned Regulatory Policy for Products Containing CBD
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- After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, the market for FDA-regulated food and dietary supplement products that contain cannabidiol (CBD) continues
Update on FDA’s New Era of Smarter Food Safety Initiative in Light of COVID-19
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- Last year we reported on FDA’s announcement on the “New Era of Smarter Food Safety”, an effort intended to combine the implementation of Food Safety Modernization Act (FSMA) with new
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Continue Reading Update on FDA’s New Era of Smarter Food Safety Initiative in Light of COVID-19
FDA Pays Closer Attention to How Food and Dietary Supplement Companies Promote Their Products on Social Media
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- As consumers spend more time online during COVID-19, FDA has increased its oversight of product claims made through testimonials, customer reviews, and blog posts posted to company social media accounts
Federal Judge Orders Permanent Injunction for Repeated FDCA Violations
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- On May 27, 2020, U.S. District Judge Edgardo Ramos in the U.S. District Court for the Southern District of New York entered an order of permanent injunction against two individuals
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Continue Reading Federal Judge Orders Permanent Injunction for Repeated FDCA Violations
FDA and FTC Issue Warning Letters to Companies Marketing and Selling Products Deemed Fraudulent for the Treatment or Prevention of COVID-19
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- On May 26, 2020, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint warning letters to four companies for the marketing and sale of products