By Lou Caputo On February 8, 2013, the White House Office of the Press Secretary released a Fact Sheet memorandum entitled “Examples of How the Sequester Would Impact Middle Class Families, Jobs and Economic Security.” The memo offered hypothetical examples of how the automatic budget cuts, known as “sequestration,” could affect various federal agencies, such […]
By Lou Caputo Congress has indicated that it may postpone the impending debt ceiling crisis as part of a compromise that would also extend the time for a budget resolution. HR 325 extends the last day to decide those issues until May 18, 2013. The Senate now has the bill. This is good news for […]
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 […]
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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