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

Medicare Opt-Outs Must be Done Right

Opting-out of Medicare Part B  gives physicians greater control over the prices for their services.  But, if it is not done correctly, there are serious consequences. Regardless of whether or not a physician is a participating provider in the Medicare program, he or she must submit claims to Medicare for items and services he or […]

Combination OTC Drug/Supplement Products

By Lou Caputo The FDA recently issued its Final Rule concerning good manufacturing practice requirements for combination products.  For those engaged in the dietary supplement industry and familiar with combination products, it comes as no surprise that there is no mention of dietary supplements in the Final Rule.  The Rule stands as another reminder, however, […]

Pharmacy Compounding Under Greater Scrutiny from FDA

FDA has taken a relatively hands off approach to pharmacy compounding in the past, but that may all change after steroid injections from the New England Compounding Center resulted in a deadly fungal meningitis outbreak. Under FDA’s tiered regulatory approach concerning pharmacy compounding, state boards of pharmacy regulate traditional compounding and FDA regulates nontraditional compounding.  […]

Cooperation with FDA Beneficial During Recalls

There are two types of product recalls:  mandatory and voluntary.  Prior to the Food Safety Modernization Act (“FSMA”), FDA did not possess mandatory recall powers with respect to foods, excluding infant formula.  Rather, the agency was limited to requesting that a firm voluntarily initiate a recall, which it usually reserved for urgent situations.  If the […]

Device Companies Taxed to Death

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 […]

EU Maximum Vitamin and Mineral Dose Levels

In an excellent piece by Shane Starling in today’s, 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 […]

FDA Delays in Response to Rulemaking Petitions

By Lou Caputo The Administrative Procedure Act sets out the general process for rulemaking for federal agencies. 5 U.S.C.A. § 553 (West).  Under the rule, any “interested person” may petition for the “issuance, amendment, or repeal of a rule.” 5 U.S.C.A. § 553(e) (West).  The Act requires agencies to issue “prompt notice” when they deny […]

The Uncoupling of Injury from Adulteration

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 […]

The Pyridoxamine Trap

When evaluating whether an ingredient can be used in a dietary supplement, one must assess not only whether the ingredient is a new dietary ingredient (“NDI”), i.e., “a dietary ingredient that was not marketed in the United States before October 15, 1994,”  21 U.S.C.  § 350b(d), but also whether prior to its sale as a dietary […]

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