This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
- Here comes CRISPR – gene-edited plants will soon hit grocery stores and dinner tables. According to a January 9 article in The New York Times, the longstanding dispute over the regulation of GMOs may soon take a dramatic new turn as a new generation of crops that are gene-edited rather than genetically modified hits the market. These plants have been genetically altered by novel techniques such as CRISPR that tweak DNA at precise locations, rather than adding genes from other organisms. Since no genes from foreign organisms have been used, these products are not covered by federal or state laws governing GMOs; in the absence of regulation, the USDA has been allowing them once it is satisfied that they are gene-edited and not genetically modified. Federal agencies have not yet announced how, or whether, they plan to regulate gene-edited foods. "We've never been against any of this technology," Michael K. Hansen, a senior staff scientist at Consumers Union, told the Times. "We don't say it's inherently bad or these crops are inherently dangers. It's just they raise safety issues, and there should be required safety assessments."
- FDA attempts to clarify "added sugar" definition for labeling purposes. On January 5, the FDA attempted to clarify some of the confusion over defining and calculating added sugar with new draft guidance designed to help food companies understand the changes the agency is making to the Nutrition Facts panel. One of the key areas: whether natural fruit sugars that are added to a product must be disclosed as "added sugar." The FDA acknowledged that sugar is sugar, biochemically – whether it occurs naturally or is added to a product. If a fruit juice blend, for example, is reconstituted so that its sugar content is less than what would be found in the same amount of the same type of single-strength juice, the added sugar amount would be zero. Only sugar that is in excess of the amount that would be expected in 100 percent fruit juice of the same type would be declared. Public comments are due by March 6.
- Will FDA take any action on non-dairy "milk" or "cheese"? A letter sent to the FDA by 34 members of Congress in December 2016 asking that the term "milk" be prohibited in describing plant-based beverages has sparked serious debate on federal standards of identity and whether the FDA will take any action to enforce them. For example, Good Food Institute policy director Nicole Negowetti told DairyReporter.com on January 6 that there has been a frustrating lack of clarity from the FDA on its position on non-dairy "milk" – whether almond or soy products, for example, can legally be called almond milk or soy milk. Producers of plant-based milks say they remain constantly open to lawsuits, and the dairy milk industry blasts the FDA's inaction and believes that plant-based beverage companies are openly flouting the law. Manufacturers of plant-based "cheese" products find themselves in similar uncertainty. There is no indication the FDA will take action soon.
- Raw camel milk back in the news. The FDA has made public a letter it sent in the fall to Saudi businessman Walid Abdul-Wahab, whose Desert Farms company sells an array of raw camel milk products. The Santa Monica, California-based company in recent days removed from its website claims that its products help with such ailments as diabetes, autism, Crohn's disease and allergies. The warning letter says, "Your products are not generally recognized as safe and effective for the above referenced uses." While Desert Farms has removed the claims from its web pages, it has linked to the National Center for Biotechnology Information website, telling site visitors that if they are "curious enough" to know what information has been taken down, they should visit the National Center for Biotechnology Information website, "type in 'Camel milk' in the search bar and you will know why."
- Meanwhile, the operator of Missouri-based Hump-Back Dairys, who in December was warned by the FDA to cease distribution of raw camel milk and raw camel milk products across state lines, told the Springfield News-Leader he will stop selling raw milk to people outside Missouri. See more about this story here.
- Dairy-state senator introduces bill to end commercial use of terms like "soy milk." On January 12, Senator Tammy Baldwin (D-WI) introduced a bill that would force producers of plant-based milks, yogurts and cheeses to change how they name their products and would give the FDA 90 days to begin enforcement of its current standard for milk, which is defined as the "lacteal secretion … obtained by the complete milking of one or more healthy cows." The senator introduced the bill after US dairy farmers expressed unhappiness with the common industry use of such terms as "soy milk" and "vegetarian cheese." Late in 2016, a bipartisan group of 34 members of the US House of Representatives sent a letter to the FDA urging it to police the use of dairy terminology for non-milk products. The plant-based food industry expressed strong opposition. "The dairy industry is losing to the competition and all they can do is point fingers? That just seems silly," said Michele Simon, executive director of the Plant-Based Foods Association. "Nobody picks up a carton of soy milk or almond milk and thinks it’s from a cow."
- Coconut-water producer agrees to settle class action. On December 27, Harmless Harvest Inc., a manufacturer of coconut water, agreed to pay nearly $1 million to settle a class action in the US District Court for the Eastern District of New York and to change the labels on its products. In the class action, consumers had alleged that the company had misled consumers by labeling its products as "raw" and "100 percent organic." The settlement came just four days after the December 23 filing of the complaint against Harmless Harvest. The plaintiffs had alleged that the company knew that a significant portion of its coconut supply was not obtained from plantations that were certified as organic. Harmless Harvest said that it had committed no wrongdoing and that it was settling the case simply to "end costly and protracted litigation."
- Asian tapeworms in Alaskan salmon. In its journal Emerging Infectious Disease, the CDC is reporting that Diphyllobothrium nihonkaiense tapeworm has been found in wild-caught salmon from Alaska. This species of tapeworm, which can grow up to 30 feet long, has typically been found in far warmer Asian waters. The study found that several types of salmon were infected: coho, chinook, sockeye and pink, as well as rainbow trout. However, the Seattle Times notes, most North Americans should not be concerned about the danger of this parasite: in keeping with FDA rules, all raw salmon served and sold in the US is required to have been frozen to kill such parasites.