The Fourth Circuit Court of Appeals has upheld a lower court’s determination that the U.S. Food and Drug Administration (FDA) had the discretion to issue an incorrect contamination warning about Salmonella-tainted tomatoes, which devalued a tomato farmer’s crop by $15 million. Seaside Farm v. United States, No. 15-2562 (4th Cir., order entered December 2, 2016). Details about the lower court’s decision appear in Issue 588 of this Update. The lawsuit stemmed from FDA’s warning against eating raw tomatoes in 2008 following an outbreak of Salmonella that was later traced to jalapeno and Serrano peppers. Seaside Farm filed suit alleging FDA negligently issued the warning, impairing the value of its crop. The trial court found that FDA was acting within its discretion to issue the warning. Seaside argued that FDA’s warning was overly broad and based on insufficient evidence, noting that the agency failed to test any tomatoes before issuing its…
Category Archives Food and Drug Administration
The U.S. Department of Agriculture’s National Organic Program (NOP) has proposed guidance “for calculating the percentage of organic ingredients in multi-ingredient products.” Intended for accredited certifying agents and handling operations, the draft guidance responds to a National Organic Standards Board (NOSB) request for correction and clarification of the requirements codified at 7 CFR 205.302(a), which defines the method of calculating the percentage of organically produced ingredients as ‘‘[d]ividing the total net weight (excluding water and salt) of combined organic ingredients at formulation by the total weight (excluding water and salt) of the finished product.’’ Per NOSB’s recommendations, the draft guidance corrects this language “to clarify that organic percentages should be calculated by dividing the total net weight (excluding water and salt) of combined organic ingredients at formulation by the total net weight (excluding water and salt) of all ingredients,” as opposed to “the weight of the ‘finished product’ because most…
The U.S. Food and Drug Administration (FDA) has requested public input on how consumers use “flavored nut butter spreads and products that can be used to fill cupcakes and other desserts,” as part of its effort to establish a reference amount customarily consumed (RACC) and serving size for these products. Responding to a March 4, 2014, citizen petition filed by Nutella® manufacturer Ferrero Inc., which asked FDA to re-categorize nut cocoa-based spreads as a breakfast condiment similar to “honey, jams, jellies, fruit butter, [or] molasses” as opposed to a dessert topping, the agency notes that it has since updated certain RACCs and needs additional data “to determine the customary consumption amounts of and appropriate product category for flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored).” To decide if it needs to create a new RACC category for these products with a serving size of 1 tablespoon, FDA seeks responses to…
A New York federal court has stayed a proposed class action alleging Kind LLC misleads consumers by describing its products as “all natural” and free of genetically modified organisms. In re Kind, No. 15-2645 (S.D.N.Y., order entered September 15, 2016). The court noted that the U.S. Food and Drug Administration (FDA) requested comments on the use of the term “natural” in food labeling in November 2015 and closed the comment period in May 2016, suggesting that FDA is “prepared to address the core issues in this case.” The plaintiffs voluntarily dismissed their claims that Kind’s use of “healthy” on its labels was misleading following FDA’s determination that it would permit Kind to use the term as the agency considers redefining it. Details on that determination appear in Issue 604 of this Update. Issue 618
The U.S. Food and Drug Administration (FDA) has published a September 2016 Consumer Update describing how to determine if a product contains real maple syrup as a flavoring agent. Specifically, the agency urges consumers to look at the ingredient list for the term “maple syrup” and not rely solely on depictions of maple leaves or the word “maple” displayed on the front of packaging. “Current regulations allow use of terms like ‘maple,’ ‘maple-flavored,’ or ‘artificially maple-flavored’ on the food label without having any maple syrup in the product, as long as it contains maple flavoring,” clarifies FDA. “This flavoring could come from a number of sources, including sap or bark from the maple tree. Or it could come from the herb fenugreek, which can impart a maple-like flavor.” Noting that similar rules apply to some fruit flavorings, the agency explains that terms such as “artificial flavors” or “natural and artificial…
The U.S. Food and Drug Administration (FDA) has opened a docket and released industry guidance on the use of the term “healthy” in the labeling of human food products. Responding to Kind LLC’s citizen petition asking the agency to align its nutrient content claim regulations with federal dietary guidance, FDA invites “public comment on the term ‘healthy’, generally, and as a nutrient content claim in the context of food labeling.” Current regulations reportedly establish “the parameters for use of the implied nutrient content claim ‘healthy’ or related terms… on the label or in labeling of a food to suggest that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions, and the claim is made with an explicit or implicit claim or statement about a nutrient.” Among other things, the conditions take into…
Several consumer-protection groups, including the Natural Resources Defense Council (NRDC) and the Center for Science in the Public Interest (CSPI), have filed a citizen petition with the U.S. Food and Drug Administration (FDA) urging the agency to withdraw approval of seven antibiotics for disease prevention and growth-promotion use in livestock and poultry. “The use of medically important antibiotics in livestock production for growth-promotion or disease-prevention purposes is not shown to be safe,” the September 13, 2016, petition asserts. “FDA’s voluntary program will not end these drug uses. FDA must immediately begin proceedings to withdraw approval for these uses.” The day before the groups filed the petition, FDA announced a comment period about therapeutic uses of medically important antimicrobials. The agency seeks information about (i) “[t]he underlying diseases requiring these drugs for therapeutic purposes, and periods when livestock or poultry are at risk of developing these diseases”; (ii) “[m]ore targeted antimicrobial…
The U.S. Food and Drug Administration (FDA) has extended the public comment periods for draft guidance “that provides practical, voluntary sodium reduction targets for the food industry.” Titled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods,” the guidance sets short- and long-term sodium targets for the following food categories: (i) cheese; (ii) fats, oils and dressings; (iii) fruits, vegetables and legumes; (iv) nuts and seeds; (v) soups; (vi) sauces, gravies, dips, condiments and seasonings; (vii) cereals; (viii) bakery products; (ix) meat and poultry; (x) fish and other seafood; (xi) snacks; (xii) sandwiches; (xiii) mixed ingredient dishes; (xiv) salads; (xv) other combination foods; and (xvi) baby/toddler foods. The agency will now accept comments pertaining to the food categories and two-year salt reduction goals until October 17, 2016. The comment period for the 10-year targets as well as feedback on technical…
The U.S. Food and Drug Administration (FDA) has extended until July 26, 2018, the deadline for posting the calorie counts of “certain gums, mints, and roll candy products” sold in glass-front vending machines, as well as for complying with type-size front-of-pack (FOP) labeling requirements. Published December 1, 2014, and effective December 1, 2016, the final rule requires businesses operating 20 or more vending machines to clearly disclose calorie counts “in a direct and accessible manner” if calories are not easily visible to prospective purchasers via FOP labeling. According to FDA, “several trade associations requested the extension for glass-front vending machines because of concerns regarding the requirements for the size of front-of-pack (FOP) calorie disclosures.” The trade associations apparently noted that “current voluntary FOP labeling programs require calorie information to be presented in a type size that ranges from 100 to 150 percent of the size of the net weight contents…
The U.S. Food and Drug Administration (FDA) has filed an opposition to a petition for a writ of mandamus seeking a response to several consumer groups’ petition to prohibit perchlorate, an additive currently approved for limited use in food packaging. Breast Cancer Fund v. FDA, No. 16-70878 (9th Cir., petition filed July 8, 2016). The groups’ petition urged the Ninth Circuit Court of Appeals to compel FDA to respond to their December 2014 food additive petition, arguing the agency was required to respond by June 2015. Details about the petition for a writ of mandamus filed by the groups—which include the Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Working Group and the Natural Resources Defense Council—appear in Issue 599 of this Update. FDA’s response first challenges the group’s standing to sue. “Even if petitioners could demonstrate that perchlorate poses some risk…
