Author: lcaputo

Amongst all of the important local proposals voted on yesterday across a multitude of states, few were arguably more important than Initiative Measure No. 522, a public initiative in Washington state.  With thousands of ballots still left to be counted, the Seattle Times reports that 522 trailed late 45% to 55%, and intimated that the […]

On June 19, 2013, Emord & Associates, on behalf of Youngevity, Inc., filed a Comment to FDA’s proposed rule, “Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements.”  If adopted, the Rule would require inclusion of selenium as an essential nutrient in infant formula. FDA concluded […]

In the midst of supposed cinching of financial waist belts and hard budget choices, the FDA announced this past week that it would begin investigating the “trend” in foods that are being manufactured to include caffeine.  The announcement was thereafter memorialized on the FDA’s website.  This news arrives in the advent of Mars, Inc. announcing […]

In my last post, I explained the broad regulatory scheme maintained by the Food and Drug Administration and how the agency and the Department of Justice have been increasingly going after corporate executives in companies that have allegedly violated the Food, Drug, and Cosmetic Act (FDCA) and related statutes.  That new focus is part of […]

If you have had occasion or reason to interact with the FDA, it may come as little surprise that the FDA maintains arguably one of the broadest regulatory schemes in the United States.  The Food, Drug, and Cosmetic Act (FDCA) as well as other legislation such as the Food Safety and Modernization Act allocates the […]

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 […]

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 […]