Virginia (202) 466-6937 | Arizona (602) 388-8899

Current FDA Appears Not to Follow FDA’s Informal Two-Click Policy

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 […]

FDA Requests Comments on Food Allergen Thresholds

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 […]

FDA GMP Warning Letters to Target Finished Product Testing

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 […]

How the FDA Defeated 21 USC 343(r)(3)(C)

By Jonathan W. Emord Emord Blog at   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 […]

Think Twice Before Asking Congress for Help

By Jonathan W. Emord Emord Blog at   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 […]

FTC’s False Negative Regime Violates the First Amendment

By Jonathan W. Emord Emord Blog @   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’s Extra Statutory Power to Demand Financial Restitution from Regulatees

In 1999, the United States Court of Appeals for the Sixth Circuit decided United States v. Universal Management Services, 191 F.3d 750, finding that restitution was a proper equitable remedy for a violation of the Food, Drug, and Cosmetic Act, despite the absence of statutory authority.  The decision has since been the topic of debate […]

Is FDA’s Alleged Reconsideration of its Draft NDI Guidance a Subterfuge?

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 […]

FDA Granted Broad Authority to Regulate Stem Cell Clinics

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 […]

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