As previously reported here, in the prior administration, FDA had an unwritten and informal enforcement policy that that allowed a website selling dietary supplements to link to scientific literature discussing nutrients in those supplements and diseases, provided that the page containing the scientific literature was at least “two clicks” away from product pages in question. […]
By Jonathan W. Emord FDA and EFSA censorship regimes are based on an anti-fraud or anti-deception rationale. In short, FDA presumes that deprivation of all information not officially sanctioned that expressly or impliedly links a nutrient with a disease helps prevent consumers from being misled. Likewise, EFSA presumes that deprivation of all information not officially […]
In response to mounting public pressure, Senator Barbara Boxer (D-CA) and Representative Peter DeFazio (D-OR) introduced companion bills in the Senate and House of Representatives requiring GMO labeling. The Genetically Engineered Food Right-to-Know Act would amend the Federal Food, Drug, and Cosmetic Act to state that a genetically engineered food or a food that contains […]
Do you think you are intelligent enough to decide for yourself the relative worth of scientific findings concerning the disease treatment and risk reduction effects of nutrients and foods? The FDA thinks you are not and that it must decide such questions for you in the first instance. Indeed, the FDA bans from the grocery […]
As previously noted here, we expected FDA’s enforcement activities and scrutiny of compounding pharmacies to increase after last year’s deadly outbreak of fungal meningitis tied to steroid injections compounded by the New England Compounding Center (“NECC”). Recently, FDA took steps to determine whether certain compounding pharmacies known to have produced high-risk sterile drug products in […]
FDA requested from Congress a budget of $4.7 billion for fiscal year (“FY”) 2014, which covers the period from October 1, 2013 through September 30, 2014. That amount represents an increase of $200 million from the $4.5 billion requested for FY 2013. According to FDA Commissioner Margaret Hamburg, M.D., FDA requires a larger budget because […]
On April 5, 2013, the Alliance for Natural Health USA (ANH) and Certified Board for Nutrition Specialists (CBNS) each filed comments opposing a Medicare reform regulation proposed by the Centers for Medicare & Medicaid Services (CMS). CMS proposed regulatory revisions to promote program efficiency, transparency, and burden reduction. See 78 Fed. Reg. 9216-01 (Feb. 2013). […]
Senator Dick Durbin (D-IL) plans to reintroduce a disastrous bill called the Dietary Supplement Labeling Act, which is aimed at further regulating the dietary supplement industry. The bill was originally introduced in 2011 as S. 1310. The bill requires food facilities that manufacture dietary supplements to submit the following information when registering with the FDA […]
On February 7, 2013, the Center for Medicare and Medicaid Services (CMS) published a proposed rule in the Federal Register, 78 Fed. Reg. 9216 (Feb. 7, 2013). Buried in that rule is a proposed revision to Section 482.28 of 42 CFR Part 482 concerning Food and Dietetic Services. At present, that rule requires a therapeutic […]
In a recent opinion, the Federal Trade Commission (“FTC”) affirmed in part and reversed in part an Administrative Law Judge’s decision that Pom Wonderful deceptively advertised its products. According to the Commission, Pom Wonderful did not have sufficient substantiation to support claims the FTC deemed implied that POM’s products could treat, prevent, or reduce the […]
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