03 December 2018, by Stefanie Jill Fogel, Kathleen Smith Ruhland, Maggie Craig
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
- Hearings on Brashears nomination. On November 28, the Senate Committee on Agriculture, Nutrition, and Forestry held hearings into the nomination of Dr. Mindy Brashears to serve as the USDA's Under Secretary for Food Safety – the top food safety official in the nation. Dr. Brashears, a professor of food microbiology and food safety at Texas Tech University and a highly regarded expert in food safety issues in pre- and post-harvest environments, told the senators her primary goals in the post would be to protect public health; modernize food safety systems; address emerging public health threats; and work closely with the FDA and the FSIS. Some consumer advocates opposed her nomination – the Organic Consumers Association, for instance, ran a campaign called "Tell Your Senators: Don't Put a Scientist-for-Hire in Charge of Food Safety!" However, media outlets are describing the Brashears hearing as thorough but positive – in fact, Food Safety News noted that were it not for rules prohibiting a same-day confirmation vote, her nomination would immediately have been sent to the Senate floor. The Under Secretary for Food Safety post has been vacant for nearly five years.
- Romaine in the news. The FDA and CDC now say that most US-grown romaine is safe to eat, except romaine from California's northern and central coast. Investigators, the agencies said on November 26, have traced the latest E. coli outbreak to "end of summer" romaine from those areas. On November 20, FDA requested that all romaine lettuce on the market, including in restaurants and other commercial establishments, should be withdrawn and destroyed, "to purge the market of potentially contaminated romaine lettuce related to the current outbreak." The agency concluded, "This appears to have been accomplished." After last year's widespread E.coli outbreak was traced to romaine from Yuma, Arizona, growers there put in place extensive new protocols aiming to eliminate contamination in their produce. One outcome of all these outbreaks: an agreement between FDA and the leafy greens industry that all packaged romaine sold in the US will bear a label indicating its harvest region and date of harvest. The industry also will establish a task force that will examine labelling issues for all leafy greens and put in place standards for traceability of product. During the winter season, which has just begun, most leafy greens consumed in the US come from Yuma, with modest amounts also being produced in Florida, the Imperial Valley and Mexico.
- Will Florida act to permit interstate wine shipments? According to a November 27 article in Wine Searcher magazine, Florida appears to be the next battleground in the effort by some advocates to bring about full interstate shipping of wine. Indianapolis attorney Robert Epstein has announced that he has filed a petition for a declaratory statement from the Florida Division of Alcoholic Beverages and Tobacco requesting that the state agency permit out-of-state retailers to ship wine into Florida. Epstein has filed similar cases in Michigan, Missouri and Illinois. No date has yet been set for a decision by the Florida state agency, but Epstein says a decision will need to be made in nine to 12 months.
- Kentucky wineries want relief from regulatory requirements. On November 13, WVXU, a public radio outlet in Cincinnati, aired a report about several Kentucky wineries that are asserting that state regulation is stifling their industry. The wineries are asking for relief. For example, if a winery grows too large, at 100,000 gallons of wine per year, it is no longer permitted under state law to run wine tastings. Only "small wineries" can do so in Kentucky. There are other limitations as well. In 2016, the state legislature increased the "small winery" limit from 50,000 gallons to 100,000, but the industry wants it further raised to 250,000 gallons. Although in 1796 Kentucky became the first state to have a commercial winery, the wine industry there has lagged for decades behind bourbon and tobacco.
- FDA approves qualified health claim for oleic acid. In a November 19 announcement, the FDA approved a qualified health claim for edible oils containing high levels of oleic acid, a monounsaturated fat that has been shown to have benefits for the cardiovascular system when it replaces saturated fat. High levels of oleic acid are found in olive oil, as well as types of safflower oil, sunflower oil, canola oil and soybean oil. The approved qualified health claim language reads "supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, may reduce the risk of coronary heart disease." Products making the qualified health claim must also include a statement that these oils should replace other oils that are higher in saturated fats and should not be used to increase total caloric intake. FDA Commissioner Scott Gottlieb said in a statement, "These claims serve as efficient signals that consumers can look for on a product's packaging to determine what benefits a food or beverage might have. By allowing such claims on food product labels, we at the FDA also hope to encourage the food industry to reformulate products."
- TTB announces new labeling and advertising rules to reduce burden on industry. On November 26, the Alcohol and Tobacco Tax and Trade Bureau (TTB) set forth a detailed set of new regulations designed to revamp the federal regulations concerning the labeling and advertising of wine, distilled spirits and malt beverages. The agency says it is proposing to "reorganize and recodify these regulations in order to simplify and clarify regulatory standards, incorporate guidance documents and current policy into the regulations, and reduce the regulatory burden on industry members where possible." Comments from the public on the proposed regulations are due by March 26, 2019. The TTB said the rulemaking is the latest phase of its multiyear effort to facilitate commerce through a modern labeling program focusing on service and market compliance by the industry.
- TTB warns alcohol industry about prohibited retailing practices. On November 8, the federal Alcohol and Tobacco Tax and Trade Bureau (TTB) issued a compliance circular warning the alcohol industry of several prohibited trade practices. Among them are the payment by wineries, distillers or brewers of fees to retailers in exchange for display space or shelf space; the offering of sponsorship agreements that are tied to product placement or exclusivity arrangements; and the use of third-party marketing companies to surreptitiously provide things of value to retailers. "The high incidence of unlawful activities and deliberate concealment of such activities raise serious concerns. These activities are of particular significance because of their nationwide occurrence and their impact on trade and fair competition. We believe that the industry as a whole has the ability and desire to operate within the law," the agency wrote.
- Sugar Association decries proposal for warning label for added sugar. The Sugar Association, in response to a proposal by the American Medical Association that products with added sugars should display a warning label, said November 14 that any such proposal is misguided because sugar consumption has never been shown to cause diabetes or heart disease. The group said, "It is concerning that the United States'premier medical association would push forward a concept that lacks scientific evidence – there is no direct link between sugar intake and cardiovascular disease or diabetes." The statement continued, "We are very concerned that such a warning label would lead consumers to believe that consuming above 50 grams of sugar per day (the Daily Value) would result in an adverse health outcome. Furthermore, this is a huge step backwards for nutrition education in rehashing the concept of a single-nutrient focus that has harmed this field and made no headway in the health of the public. Haven't we learned from the demonization of cholesterol in the 80s and fat in the 90s?" The new version of the Nutrition Facts Label, which will go into effect for all companies in 2021, will require disclosure of the amount of added sugar in a product, but not in the form of a warning label.
- Nonprofit group seeks FTC investigation of sucralose advertising and marketing. U.S. Right to Know, a nonprofit consumer group, asked the Federal Trade Commission on November 19 to investigate claims that the artificial sweetener sucralose neither metabolizes nor bioaccumulates in the body. Sucralose is sold under the brand name Splenda, and the FDA approved it for human consumption nearly 20 years ago. The maker of Splenda, Tate & Lyle, says studies prove that sucralose is not recognized by the human body as a carbohydrate and is not metabolized or bioaccumulated; thus, it has zero calories. U.S. Right to Know points to a 2018 study that it says demonstrated sucralose does metabolize and bioaccumulate in the fatty issue of rats. If this is the case, says the group, it may be deceptive for companies to assert that the substance does not metabolize or bioaccumulate.