New Practice Areas: White Collar Crime and European Union Law Effective November 1, 2012, the firm is pleased to announce the expansion of its practice to include white collar crime as it pertains to alleged violations of, inter alia, the Food, Drug, and Cosmetic Act, the Postal Service Act, and the False Statements Act, among […]
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 […]
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 […]
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 […]
Although market leaders in the supplement industry appear to be coping with the present recession, most are experiencing a downturn in sales and a few are doing better than in prior years. The bulk of small to mid-sized companies are struggling, caught in a squeeze between a dramatic reduction in demand and a dramatic increase […]
The Affordable Care Act contains a provision that imposes a 2.3% excise tax, effective January 1, 2013, on the total revenues, not net profits, of all medical device manufacturers in the United States. The excise tax will force many device companies to go out of business or go off shore. For all others, it will […]
In an excellent piece by Shane Starling in today’s Nutraingredients.com, Shane explains the debate now raging in the UK over the 2002 EU Food Supplements Directive provision requiring the setting of maximum permitted levels for nutrients in food supplements. He explains that an estimated 700 health food stores and 4000 jobs would be lost throughout […]
The pyridoxamine example, well explained by Bethany in her blog post, proves the inherent pitfalls in 21 USC 321(ff)(3)(A)-(B). As we have seen, the new interpretation given by FDA to the term “New Dietary Ingredient,” the FDA’s redefinition of adulteration standards through its Good Manufacturing Practice Guidelines, and the changes effected by the Food Safety […]
It is a truism that words have multiple meanings. String them together in a sentence and greater opportunity exists for construing them to mean something other than intended by the speaker. Add to that meanings not overtly expressed but interpretable as implied and you can transform an intended meaning into an unintended one with relative […]
If you ask a consumer what makes a dietary supplement adulterated, he or she will say that it contains an ingredient or contaminant that makes it unfit for human consumption. That is, of course, the logical and historically plain meaning of the term adulteration, but that is not the meaning of adulteration FDA gives to […]
Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.
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