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

Commercialization of Qualified Health Claims

Qualified Health Claims permit nutrient-disease risk reduction claims to be made for dietary supplements without fear of FDA or FTC enforcement.  The FDA allows such claims in reliance on its “enforcement discretion,” following submission of a health claim petition.  The FDA’s “enforcement discretion” is a euphemism because the agency is constitutionally barred by precedent in […]

Emord & Associates Releases 2013 FDA Inspection Guide for Food and Dietary Supplement Companies

Emord & Associates has published an FDA Inspection Guide to help food and dietary supplement companies avoid common pitfalls associated with FDA inspections.  The guide, available for download online here, covers routine, cGMP, FSMA, and adulteration inspections.  It identifies the kinds of documents FDA ordinarily can and cannot obtain lawfully.  The guide provides general information […]

Be Careful What You Link To

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.  […]

How FDA and EFSA Prior Restraints Defeat Government Objectives and Foster Fraud and Deception

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 […]

Congress Introduces GMO Labeling Bill

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 […]

FDA Targets Compounding Pharmacies for Inspections

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 Proposes New User Fees to Support FSMA

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 […]

FDA Dislikes Supplement Company’s Facebook “Like”

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 […]

Sen. Durbin to Reintroduce Anti-Supplement Bill

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 […]

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Telephone: (602) 388-8899
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