- On January 9, the Center for Science in the Public Interest (CSPI) sent a letter to Dr. Susan T. Mayne, Director of the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, urging the Agency to “take immediate enforcement action to prevent unauthorized implied ‘low sugar’ and ‘reduced sugar’ claims, such as ‘lightly sweetened’ and ‘less sweet’ on beverage products that are high in sugar.” CSPI argues that these claims mislead consumers and are in violation of the federal Food, Drug, and Cosmetic Act (FDCA).
- In the letter, CSPI identified 19 products from 5 brands that they allege make unauthorized implied “low sugar” or “reduced sugar” claims. “Low sugar” and “reduced sugar” claims are nutrient content claims (NCCs), which are claims that expressly or implicitly characterize the level of a nutrient of the type required to be in nutrition labeling. NCCs may not be made on labels or in labeling unless the claim is made in accordance with the regulations authorizing the use of that claim. CSPI argues that claims such as “lightly sweetened,” “sorta sweet,” “slightly sweet,” and “just a tab sweet” are synonyms for “low sugar” and are therefore prohibited under federal law because “low sugar” is not a defined or permitted NCC. Similarly, CSPI alleges that some products make “less sweet” claims but do not meet the requirements to make a “reduced sugar” NCC.
- In addition to urging the FDA to take enforcement action against the manufacturers identified in the letter for making implied “low sugar” and “reduced sugar” claims, CSPI encourages the Agency to issue regulations authorizing a “low added sugar” NCC to allow the claim to be made on products that are low in added sugars. CSPI recommends the NCC be based on a per-reference amount customarily consumed (RACC) threshold, similar to the requirements for other “low” NCCs.
- Notably, Kellogg recently settled a class action lawsuit over use of the label claims “lightly sweetened,” “healthy,” “nutritious,” and “wholesome,” on select cereals, including Krave S’Mores and Cinnamon Roll Frosted Mini Wheats. Plaintiffs argued the claims implied that the cereals were low in sugar when they actually contained 18 – 40% added sugar. In response, Kellogg stated that it had never advertised the cereals as “low sugar” or “reduced sugar,” and that the sugar content was clearly listed on each product’s Nutrition Facts Panel. The class action lawsuit settled for $20 million.
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FDA’s New Enforcement Priority Guidance for E-Cigarettes Focuses on Flavored Cartridge-Based Devices and Companies and Products that FDA Views as Targeting Kids
On January 8, 2020 FDA published its new final compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Under the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of premarket review requirements for the following products:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
Importantly, FDA also intends to prioritize enforcement of any ENDS product (on the market as of August 8, 2016) that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application). The May 12, 2020 deadline was initially established by a federal district court in Maryland; that decision is now pending appeal in the Fourth Circuit.
While FDA has identified flavored cartridge-based ENDS as a primary concern for underage use, the Agency is also targeting manufacturers that are not adequately preventing minor access, and any products (open or closed system, including e-liquids sold in vape shops) that, in FDA’s view, are targeted to minors or likely to promote ENDS use by minors. FDA’s broad approach could put a significant portion of the vapor industry is at risk of immediate enforcement.
When determining whether a manufacturer is taking or has taken adequate measures to prevent minors’ access to ENDS products, the Agency will consider, for example:
- Whether adequate programs to monitor retailer compliance with age-verification and sales restrictions have been implemented;
- Whether retailers face manufacturer-established penalties for failing to comply with age verification and sales restrictions, and whether there is a policy of notifying FDA of retailer violations;
- If the manufacturer is also a retailer, whether there is an implementation of programs to ensure age-verification and sales restrictions, checking ID at the door, etc.;
- Whether the manufacturer uses adequate age-verification technology or requires that retailers use such technology to prevent minor access to its website and underage internet sales; and
- Whether a manufacturer limits or requires retailers to limit the quantity of ENDS products that a customer may purchase in a given period of time.
When determining whether an ENDS product is targeted to minors or is marketed in a manner that is likely to promote ENDS use by minors, the Agency will consider, for example:
- Whether the labeling and/or advertising of a product resembles kid-friendly foods and drinks or resemble other non-ENDS products that are appealing to youth. Here FDA highlights the numerous warning letters issued to e-liquid manufacturers over the last couple of years. Those warning letters alleged that the e-liquid products were misbranded because the labeling and/or advertising of the products (i.e., color schemes, label images, brand names, etc.) inappropriately imitated specific food products that are generally marketed toward and/or appealing to children, including cereals (e.g., Cinnamon Toast Crunch, Lucky Charms, Fruit Loops, Franken Berry), candies and snacks (e.g., Life Savers, Sour Patch Kids, Gummy Worms, War Heads, Pocky Sticks, Goobers, Tree Top Apple Juice), and desserts (e.g., Unicorn Cakes, Nilla Wafers, Reddi Wip).
- Whether marketing materials utilize youth appealing cartoon or animated characters, or use popular children’s characters and titles.
- Whether paid social media influencers are used; and
- Whether a product is promoted for being easily concealable (from parents and teachers). In this regard, FDA makes clear in the guidance that the following types of devices and device features present a unique concern for youth, even if adults may prefer these as well:
- Small size that allows for easy concealability and features that facilitate the ease of use (draw activation, prefilled cartridges or pods, and USB rechargeability);
- Small size that allow for use in school, quick concealment, product use in a social setting without others’ awareness, and products’ ability to be concealed with other equipment;
- Products with no settings to change and very little assembly required; and
- Products with features such as pre-filled cartridges, draw activated batteries, and that can be recharged via a USB ports, charging adapters or cell phone.
In short, while FDA’s focus is on the flavored cartridge and pod-systems, ENDS companies should be aware that FDA’s guidance is broad enough to capture a wide variety of open and closed-system products that may be viewed by FDA as accessible to kids, marketed to kids or easily used and/or concealed by kids.
Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California. Details and Registration information can be found here.