This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
- FDA chief uses Twitter to reach out to e-cigarette companies. In November, FDA Commissioner Scott Gottlieb announced that the agency was planning to impose severe restrictions on the sale of e-cigarette products throughout the US. On December 27, 2018, Gottlieb reaffirmed this goal, saying in a series of tweets that he remains very concerned that children’s “use of e-cigs is accelerating.” In one tweet, Gottlieb said, “I’m writing CEOs of e-cig manufacturers asking them to meet to discuss commitments they made last month, and why some are changing course.” He continued, "This is an urgent matter. We're at a critical juncture. The opportunity for harm reduction for adults could be lost for a generation." Gottlieb ended the series of tweets with a warning: "Manufacturers and management are accountable for the youth epidemic."
- TTB announces closure during government shutdown – payments, tax returns may be filed anyway. Because of the shutdown of a portion of the federal government, the Alcohol and Tobacco Tax and Trade Bureau announced on its website that it is closed indefinitely. However, while the shutdown continues, the TTB said, its website remains available; companies will still be able to file electronic payments and returns for federal excise taxes and submit eGovernment applications. Submissions will not be reviewed by the agency, however, until appropriations are enacted. No TTB personnel will be available to respond to industry inquiries during the shutdown period.
- Another regulatory hurdle for the Impossible Burger. In summer 2018, the FDA gave its "generally recognized as safe" approval to soy leghemoglobin – nicknamed heme – a substance that is the key ingredient in Impossible Foods' vegetarian Impossible Burger. Heme provides the product's convincing meat-like flavor, and its beef-like "bloody" appearance. But on December 17, the FDA said that before Impossible Foods can sell its product directly to consumers, it will need one more approval. “If the firm wishes to sell the uncooked, red-colored ground beef analogue to consumers, pre-market approval of the soy leghemoglobin as a color additive is required," an FDA spokesperson said. While the Impossible Burger is currently sold in thousands of restaurants nationwide, it is not available for sale to consumers in grocery stores or online. The company has filed a Color Additive Petition for the FDA to review the product. The agency has 90 days to complete the review and can extend the period for another 90 days.
- USDA puts forth final rules on GMO disclosures. On December 20, the USDA announced its final rules for implementation of the federal law that requires the labeling of genetically engineered, or GMO, foods. The rule was met with support from many farmer groups but with criticism from several consumer advocacy groups. Agriculture Secretary Sonny Perdue said, "This ensures clear information and labeling consistency for consumers about the ingredients in their food. The standard also avoids a patchwork state-by-state system that could be confusing to consumers." Among the key criticisms of the rule was that it requires companies to use the term "bioengineered" rather than the more commonly used terms "genetically engineered" or "GMO." The nonprofit Friends of the Earth deemed the rules "a disaster, with huge loopholes that could keep consumers in the dark as new GMOs rapidly enter our food supply. The USDA will allow some of the most common highly processed GMOs to escape labeling, and other GMO ingredients that don’t contain detectable DNA may be exempt.” Other consumer and environmental groups have also criticized the new rules, which may take effect as soon as 2020.
- Grocery manufacturers successfully implement new use-by labeling initiative. The Grocery Manufacturers Association announced on December 19 that its Product Date Labeling Initiative, created in partnership with the Food Marketing Institute, has found considerable success. The initiative focuses on voluntary labeling of products' expiration dates in only two formats: "BEST If Used By" and "USE By." The groups recognized that the vast array of expiration labels on foods not only confused consumers but led to billions of dollars of food waste each year. As a result of the initiative, said the GMA, 87 percent of food products in the US now bear one of the two preferred phrases. The group expects 98 percent adoption by the end of 2019 and complete adoption by January 2020, in time for the effective date of the new FDA Nutrition Facts panel. The voluntary standard matches the recommendation for "Best if Used By" made in December 2016 by the Food Safety and Inspection Service.
Colorado stores will now be permitted to sell all types of beer.
Under a new state law that came into effect on January 1, Colorado grocery and convenience stores are now able to sell full-strength beer for the first time since Prohibition. The law, signed by Governor John Hickenlooper last summer, includes a number of other significant changes: for instance, store clerks as young as 18 are allowed to sell spirits, wine and beer at grocery, convenience and liquor stores, and local jurisdictions may choose what kind of alcohol consumption will be allowed in public parks. Denver has already decided to allow people 21 and over to drink full-strength beer and wine in its parks and will evaluate that decision in 2020. Patrick Maroney, the state's liquor enforcement director, said, “These new regulations are some of the largest, sweeping changes to the state's liquor laws since Prohibition.” Interestingly, during the contentious legislative process, many Coloradans expressed a nostalgic affection for low-strength 3.2 beer, which most retailers have already removed from store shelves.
- Filings in much-anticipated Supreme Court case on alcohol distribution.On December 20, a wave of amicus curiae briefs were filed in the US Supreme Court in advance of a much-anticipated oral argument in Tennessee Wine and Spirits Association v. Blair. In that case, the US Court of Appeals for the Sixth Circuit struck down Tennessee’s residency requirements for people who wish to obtain retailer alcoholic beverage licenses. The libertarian Cato Institute said in its amicus brief, “While the Twenty-First Amendment affords states greater flexibility in devising alcohol regulations than regulations for other goods or services, it does not protect state laws that are mere economic protectionism. Tennessee’s durational residency requirements are thus blatantly discriminatory and protectionist, in violation of both the Commerce and Privileges and Immunities Clauses.” Oral argument is set for January 16.
- Whole genome sequencing: a key food safety development in 2018. A December 28, 2018, article in Food Safety News noted an important development that came to fruition in 2018 in the detection and identification of foodborne pathogens. This development is whole genome sequencing (WGS), a technique that allows public health officials to link seemingly unrelated patients from different places via the DNA fingerprints of specific strains of pathogens. The CDC is building a database that gives investigators the tools to match test results from sick people to pathogens isolated from food samples and thus identify and address outbreaks earlier. This means that although the number of outbreaks doesn’t necessarily change, their severity can be reduced. Using WGS, in 2018 scientists faced with a multistate outbreak of Shiga toxin-producing E. coli were able to swiftly link it to romaine lettuce grown in California in the fall. See some of our earlier coverage of that outbreak.