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 […]
Dietary supplement companies should police their social media pages for disease claims from consumers and review how their website search fields operate to reduce the risk that FDA will regulate their products as drugs. As noted in a story by the Alliance for Natural Health, FDA recently issued two warning letters to companies based upon […]
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 […]
In 2009, the International Dairy Foods Association (“IDFA”) and the National Milk Producers Federation (“NMPF”) jointly submitted a petition to FDA requesting that the agency amend standard of identity regulations to allow the use of “any safe and suitable” sweetener in optional characterizing flavoring ingredients added to milk (e.g., chocolate flavoring added to milk) and […]
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 […]
FDA announced it has received hundreds of public comments on a proposed rule implementing section 4205 of the Patient Protection and Affordable Care Act (“PPACA”). Section 4205 of PPACA requires restaurants and similar retail food establishments that are part of a chain with 20 or more locations to provide calorie and other nutrition information for […]
During the Bush Administration, FDA had an unwritten and informal enforcement policy 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. That Bush era policy appears […]
Today, FDA published a notice in the Federal Register informing the public that it is requesting comments and information on conducting a risk assessment to establish regulatory thresholds for major food allergens. 77 Fed. Reg. 74485 (Dec. 14, 2012). Comments must be submitted by February 12, 2013. The Food Allergen Labeling and Consumer Protection Act […]
By Jonathan W. Emord Emord Blog at Emord.com In the FDA Modernization Act of 1997 Congress enacted an amendment that would permit health claims to appear on the labels of foods and dietary supplements if those claims were an accurate representation of an authoritative statement made by a scientific body of the United States […]
In the POM Wonderful case, the FTC ALJ rejected FTC staff demands that certain claims there in issue had to be backed by at least two well-designed clinical trials or they would be deemed deceptive. The issue is before the full Commission and will be decided on January 18, 2013. Even if the full Commission […]
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