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 […]
According to Dr. Daniel Fabricant, Director of FDA’s Division of Dietary Supplement Programs, the agency is going through an evolution concerning its enforcement of dietary supplement good manufacturing practice (“GMP”) violations. Since the dietary supplement GMPs were rolled out five years ago, FDA’s main focus has been on enforcement against basic violations, such as the […]
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 […]
By Jonathan W. Emord Emord Blog at Emord.com On occasion, when executives of an FDA regulated company face the potential for civil or criminal prosecution, they think members of Congress potential allies. While they are undoubtedly correct that the decision to devote government resources for prosecution is invariably a political one, they are ordinarily […]
By Jonathan W. Emord Emord Blog @ Emord.com Type II errors underlie FTC’s deceptive advertising law. Those same errors cause the FTC to violate the First Amendment in the ordinary course. Getting the FTC to conform to the requirements of the First Amendment requires significant judicial or legislative action. Until the FTC changes, parties […]
FDA claims to be working on a revised “Draft Guidance: Dietary Supplements: New Dietary Ingredients” (“Draft NDI Guidance”) in light of industry concerns expressed in comments to the agency. It is unknown when a revised draft will be issued by the agency and, if issued, whether it will include any significant changes. In the interim […]
The U.S. District Court for the District of Columbia previously held that an individual’s own cultured stem cells constituted both a drug under the Food, Drug, and Cosmetic Act (“FDCA”) and a biological product under the Public Health Service Act (“PHSA”) subject to FDA regulation. U.S. v. Regenerative Sciences, LLC, 2012 WL 2989988 at *6 […]
By Jonathan W. Emord As Bethany Kennedy explains in her recent post, the Federal Trade Commission’s staff expects advertisers of health benefits to possess competent and reliable scientific evidence in advance of advertising a health benefit claim. In particular, that means an advertiser must have written evidence on hand before advertising. The absence of the […]
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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