As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products. In June of 2016, the Agency held a public meeting to solicit stakeholder feedback on its ideas. Since that time the proposal to develop an OTC Monograph User Fee Program has matured and it is generating considerable steam. However, FDA cannot implement such a program to assess user fees against members of private industry unless and until it has statutory authorization from Congress to do so.

As the Agency explains it, “A user fee program for nonprescription monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.” General partisan gridlock in D.C. notwithstanding, it appears likely that Congress may enact the legislation necessary to create this new User Fee Program during its current session (2017-18). This post updates legislative and FDA activities in this area since our introductory discussion in 2016. Continue Reading OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency when it settled a lawsuit related to its implementation of FSMA (our posts on the previous six FSMA rules are here, here, and here). The newest Final Rule, titled Mitigation Strategies to Protect Food Against Intentional Adulteration, has an effective date of July 26th. Responding to calls from affected stakeholders that a one-year compliance deadline from the effective date, as proposed originally, would not be enough time for companies to meet these significant and brand-new obligations, FDA has increased the compliance dates to 3 years for most businesses (along with 4 years for “small” and 5 years for “very small” businesses, as those terms are defined in the Final Rule).

The purpose of these new regulations, according to FDA, “is to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm,” and they establish requirements for covered food facilities to implement various food defense measures. Food defense consists of efforts to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means.  Continue Reading The Last Set of Major FSMA Regulations Are Done!

Last week, FDA finalized new food safety regulations seeking to ensure the sanitary transport of human and animal food, as required under the Food Safety Modernization Act (FSMA). The final Sanitary Transportation of Human and Animal Food Rule will affect shippers, loaders, carriers, and receivers of food transported by rail or motor vehicle in the United States. Among other sanitary controls, the rules will require that vehicles are adequately cleaned, designed to maintain safe temperatures, and operated by personnel trained in sanitary transportation practices and documentation.  Most affected entities will have a one-year compliance deadline, with smaller businesses getting an additional year.

As our readers may know, this Final Rule is the sixth of seven “foundational” rules being promulgated by the Agency under FSMA, the massive food safety overhaul law enacted in 2011.  Interestingly, unlike the other major FSMA rules, this one originated in a 2005 law called the Sanitary Food Transportation Act – Congress reminded the Agency to follow through on those mandates through a provision in FSMA.  Continue Reading A Decade Later, Rules for the Sanitary Transportation of Food Finally Finalized by FDA

FDA Food Safety and Modernization Act On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many reported incidents of food-borne illness during the 2000s.

FSMA’s goal is to ensure that food in the United States is safe by shifting the focus of federal regulators from responding to contamination to preventing contamination from initially occurring.  The law has given FDA new authority to regulate the way foods in the United States are grown, harvested, and processed.  One means through which FDA exercises this authority is rulemaking.

The four rules for which FDA is proposing changes are: Continue Reading FDA Announces More Changes to FSMA Implementation Rules