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, […]
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 […]
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 […]
By Lou Caputo Among the so-called winners and losers of Congress’ American Taxpayer Relief Act of 2012 (ATRA), otherwise referred to as the “Fiscal Cliff Bill,” the FDA and other agencies narrowly escaped having their federal allowance trimmed. This comes as welcome news to the agency; however, those who consider the FDA budget currently bloated […]
A dietary supplement distributor that uses a contract manufacturer to make its dietary supplement can be held liable for the contract manufacturer’s failure to comply with current good manufacturing practices (“CGMPs”). Accordingly, distributors should ensure that their contract manufacturers follow CGMPs. According to the CGMP final rule, a company must only “comply with the CGMP […]
By Lou Caputo As explained in the last post, there are inherent, albeit sometimes narrow, differences between those MLM’s that truly operate as legitimate businesses and others that do not. Depending on the circumstances, a business under federal investigation may become financially and functionally paralyzed as a result of the seizure and subsequent forfeiture of the […]
By Jonathan W. Emord When the Federal Trade Commission commences a non-public investigation of a company it suspects of deceptive health benefit advertising, it oftentimes resorts to use of a civil investigative demand, which is an administrative subpoena. The Supreme Court has upheld sweeping use of investigative powers by the federal government prior to the […]
One of the cases the U.S. Supreme Court will decide next year is the David and Goliath like suit between an Indiana soy bean farmer, Vernon Bowman, and Monsanto Co., the producer of seeds that are genetically engineered to be resistant to glyphosate based herbicides, including Monsanto’s Roundup. Farmers that plant Roundup Ready® crops can […]
By Lou Caputo Legal debate centers on whether certain multi-level marketing (“MLM”) business structures are legitimate or fraudulent. The Sixth Circuit has explained that no definitive boundary “separates illegal pyramid schemes from legitimate multilevel marketing programs; to differentiate the two, regulators evaluate the marketing strategy (e.g., emphasis on recruitment versus sales) and the percent of […]
We received word today that the President of Emord & Associates, Jonathan W. Emord, has been nominated for the prestigious 2012 WEGO Health Activist Award. Many of you are aware of his achievements for health freedom. You may not know that in addition to defeating FDA censorship on health claims 8 times in federal court, […]
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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