As we’ve previously written about, 2016 represented a regulatory sea change for manufacturers, distributors, and retailers of e-cigarettes and other electronic nicotine delivery systems (ENDS), who became subject to FDA oversight and requirements under the May 2016 Deeming Rule for tobacco products. In Monday’s Federal Register, FDA issued a final rule to exclude products derived from tobacco from Federal regulation as “tobacco products,” if or when such products are intended for use as a drug, device, or combination product (the “Final Rule”). In other words, the Agency has formally clarified that even a product made or derived from tobacco may be regulated as a medical product if it is intended for use in a way that meets the legal definition of “drug” or “device.”

However, FDA’s attempt to apply further requirements and restrictions on tobacco-derived products comes amid intense government wrangling over how to regulate products like ENDS more generally. It also comes at the eleventh hour of the Obama Administration and in the face of a Republican-controlled Congress that has expressed an interest in repealing, or at least reviewing, a large proportion of Federal agency rulemakings completed in the past several months. So it is worth noting that although this Final Rule could have a profound effect on marketing schemes for tobacco products, drugs, and medical devices alike, Congress’s recent passage of the Midnight Rules Relief Act could eliminate the rule before it ever takes effect (set for February 8, 2017). Continue Reading FDA Finalizes Tobacco Product Intended Use Rules, Under a Risk of Rescission by Congress

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other interested parties, including dozens of plaintiffs in lawsuits stemming from battery explosions and other injuries.  Newly enacted Federal requirements for ENDS and their components and parts show that such scrutiny sometimes leads to legislative or administrative actions.  Indeed, Summer 2016 could down in infamy for manufacturers, distributors, and retailers of this category of consumer products due to its confluence of new regulations from two major Federal agencies – CPSC and FDA.

We previously reported on the  Child Nicotine Poisoning Prevention Act of 2015, introduced last year by Senator Bill Nelson (D-Fla.) and signed into law in January.  It requires liquid nicotine to be packaged in accordance with the Poison Prevention Packaging Act and CPSC’s standards child-resistant packaging and containers (children are those under age five).   Continue Reading E-Cigarette Makers Contending with New CPSC and FDA Regulations

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

On August 5, 2013 the FDA issued its final rule on the voluntary labeling of food gluten-free. This is good news for both consumers and manufacturers.

The rule, promulgated under the Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCPA”), provides that food can be labeled “gluten-free,“ “no gluten,” “free of gluten,” or “without gluten” where it does not contain an ingredient that is:

  • a gluten-containing grain
  • derived from a gluten-containing grain and has not been processed to remove the gluten; or
  • derived from a gluten-containing grain that has been processed to remove the gluten and where the finished food product constitutes 20 parts per million or more gluten.

Food that inherently does not contain gluten, like carrots, may also be labeled gluten-free so long as it does not contain 20 parts per million or more of gluten.  Manufacturers must be in compliance by August 5, 2014.

By setting a consistent, threshold standard, health conscious consumers and those with celiac disease should have greater confidence in manufacturers’ labeling.  The clear guidelines should also have a chilling effect on private false labeling claims by shifting the litmus test of liability from a ‘reasonable consumer’ standard to a discrete threshold.  The rule will also provide the predicate for manufacturers to move to dismiss private civil suits based on federal preemption.  Overall, the rule should have the effect of encouraging more manufacturers to label their compliant products gluten-free.