New compliance rulesOn consecutive days last month, both the Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) made clear that delays in reporting potential product hazards or defects could significantly damage a company’s reputation and bottom line. The message from these agencies is clear—manufacturers and distributors of products regulated by CPSC and/or FDA would be wise to ensure their product quality processes and compliance programs enable swift communication to regulators and the public. On January 18, FDA Commissioner Scott Gottlieb announced the publication of a draft guidance that “better describes the FDA’s policy on public warning and notification of recalled products as part of [the agency’s] effort to ensure better, more timely information reaches consumers.” The next day, the U.S. Department of Justice announced that a federal district court awarded $5 million in civil penalties in an action brought on behalf of the CPSC against a pharmaceutical company for alleged violations of the Poison Prevention Packaging Act (PPPA) and Consumer Product Safety Act (CPSA), including its failure to “immediately” notify the CPSC once it discovered that its products were not compliant with the PPPA.

The FDA’s draft guidance applies to voluntary recalls of all products under FDA’s purview, including food, drugs, medical devices, and cosmetics. It comments on a variety of issues associated with product recalls, including whether the general public should be informed, and, if so, what the content and method for communication should be. With respect to timing, the draft guidance notes that the agency’s expectations will be driven largely by the nature of the risk presented by the individual recall, although it generally expects firms to issue a public warning within 24 hours of FDA notifying the firm that it believes a public warning is appropriate.


Continue Reading FDA, CPSC & the Need for Speed: Recent Actions Highlight Importance of Promptly Reporting Product Safety Issues

While there are many questions surrounding the regulation of marijuana and related products, the FDA has made it clear where it stands on at least one issue.  For the third year in a row, the FDA has issued a rash of warning letters to the makers of products containing cannabidiol (“CBD”) for marketing unapproved new drugs. CBD is a non-psychoactive compound derived from marijuana, which we’ve heard is used by many to treat symptoms including pain, anxiety, depression and insomnia.[1] The FDA letters assert that each of the companies’ claims regarding their CBD products cause them to be considered drugs, because they purport to be intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body. Such claims are a trap for the unwary because a sloppy marketer can inadvertently cause a relatively innocuous product to be subject to strict regulation as a drug. In this case, however, even a novice would conclude that the companies’ claims were disease related:
Continue Reading FDA Harshes the Vibe of CBD Makers, Warns Them to Stop Making Drug Claims

jelly donutThe Affordable Care Act (ACA) gave our nation “Obamacare.” The ACA also gave the FDA the obligation to adopt regulations requiring “a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name” to disclose the calories contained in “standard menu” items. This largely ignored ACA requirement, except by the chain restaurant industry, has yet to be implemented. It may never be.

The public health premise of requiring calorie disclosure is that it will affect positively consumer choice. Consumers will, so the theory goes, be less likely to eat what is “bad” for them (or more likely to eat what is “good” for them) if they are told that a jelly donut with a dollop of whipped cream on top is so loaded with calories that eating it will far exceed one’s daily calorie requirements.

The public health need for trying to influence consumers (restaurant eaters) to choose lower calorie items is clear. FDA’s Commissioner Dr. Scott Gottlieb wrote recently that “more than a third of U.S. adults are obese.” The question is not the need, but the practical feasibility, of addressing obesity and related health issues through a national system of menu labeling.


Continue Reading Will FDA Be Forced To Eat Menu Labeling?

soft drinkSan Francisco found itself in a sticky situation after the Ninth Circuit struck down a city ordinance that would have required soda companies and other makers of sugar-sweetened beverages to place the following warning on their ads:

WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.

Advertisers challenged the ordinance under the First Amendment and sought a preliminary injunction to halt its enforcement, but lost in the district court. The Ninth Circuit reversed, agreeing with advertisers that the ordinance unconstitutionally chilled their protected commercial speech because the warning was too one-sided and burdensome – constituting 20% of an ad’s space – and that advertisers were likely to discontinue advertising completely.


Continue Reading 9th Circuit Delivers Sweet Victory to Soft Drink Advertisers

sunshineThe coming of spring has been accompanied by good news for two food marketers—ConAgra and Bumble Bee Foods—in their respective court fights in California.

In the Northern District of California, a federal judge dismissed a putative class action against ConAgra alleging that the marketer’s Crunch N’ Munch product violated California’s unfair competition law since it contains partially hydrogenated oil (PHO), a food additive high in trans-fat. The complaint, filed by Tony Walker, specifically stated, “although safe, low-cost, and commercially acceptable alternatives to PHO exist, including those used in competing brands and even in other ConAgra products, ConAgra unfairly elects not to use safe alternatives in Crunch ‘n Munch in order to increase its profits at the expense of the health of consumers.”


Continue Reading Springtime for Food Marketers? Two Big Wins in California in Recent Days

orange splashWhich foods deserve to be labeled as “healthy?” The FDA considered this question at a public meeting on March 9th.

This public meeting was the latest stop on the FDA’s journey to redefine the term “healthy” in food labeling. The journey started almost 2 years ago in March 2015 when KIND received a warning letter from the FDA stating that many of its products labeled “healthy” were misbranded. KIND’s products, of which nuts are a primary ingredient, exceeded the “low saturated fat” threshold required to make the nutrient content claim “healthy” under FDA regulations.


Continue Reading Process to Redefine “Healthy” Moves Forward with FDA Public Meeting

jellyfishHave you seen an ad like this (we have, more times than we can remember): “Ever walk into a room and forget why? Spend extra time looking for your car keys or purse? Have trouble remembering names or faces?”

If the answer is yes, the dietary supplement Prevagen may be just what the doctor ordered.

That’s because Prevagen contains the active ingredient apoaequorin, a dietary protein originally derived from a species of jellyfish living in the Puget Sound. (Don’t worry—no jellyfish are harmed in the making of Prevagen.) According to Prevagen’s marketers, this dietary protein can help reduce common memory problems—now you remember where you put those car keys—that we begin to encounter all too often as we age.

Or maybe not.


Continue Reading FTC, New York AG File Complaint Against Marketers of Dietary Supplement Prevagen

Last week, the Southern District of New York dismissed with prejudice a putative consumer class action alleging that containers for Muscle Milk protein powder violated New York consumer protection laws because they were approximately one-third empty at the time of purchase. More specifically, the plaintiff’s Amended Complaint contended that “Defendant CytoSport, Inc. intentionally packaged its Muscle Milk powder products . . . in large, opaque containers that contain approximately 30% or more of empty space” and that “[c]onsumers, in reliance on the size of the containers, paid a premium price for [the products] which they would not have purchased had they known the containers were substantially empty.”

This case involves a challenge to what is known in the legal vernacular as food container “slack-fill,” which is the empty space in a food product container (usually the space between the food itself and the container’s opening; think of a bag of potato chips). More technically, the FDA defines slack-fill as “the difference between the actual capacity of the container and the volume of the product contained therein.” Under the federal Food, Drug and Cosmetic Act (FDCA) and FDA regulations implemented thereunder, a food product is considered misbranded “[i]f its container is so made, formed or filled as to be misleading.” Similarly, a container is misleading under FDA regulations if its contents cannot be fully viewed and it contains “nonfunctional slack fill.” So unless you are using clear plastic packaging or some other form of packaging where consumers can easily see exactly how much is inside, you need to look at how much slack-fill is present and why.


Continue Reading Slack-Fill Consumer Class Action Challenge Not Enough Muscle to Survive

sunblockAt last year’s Kennedy Center Honors, Aretha Franklin brought down the house and brought President Obama to tears with her rendition of Natural Woman. Marketers relying on “all natural” claims also may feel like crying these days. We’ve blogged frequently about natural claims; see this recent post. Much of the misery in this area results from confusion over the use of the term “natural” in food. The Food and Drug Administration (FDA) has requested public comments on the use of the term, issued rather circular non-binding guidance, but thus far not issued regulations. The Federal Trade Commission (FTC) also has refused to issue guidance regarding natural claims. All of this confusion, however, will not stop the FTC from going after marketers making “all natural” claims that the FTC deems deceptive. In April, we discussed the FTC suing several marketers of sun screen and beauty products for deceptive all natural claims based on the presence of synthetic ingredients in the products. Four of those companies choose to settle, one choose to fight the FTC on the FTC’s home court — administrative litigation. Anyone want to guess how that turned out?

On December 12th, the FTC announced that it had granted summary decision in staff’s favor against California Naturel, Inc. The personal care products sold by California Naturel include an “all natural” sunscreen with SPF 30, which California Naturel described on its website as containing “only the purest, most luxurious and effective ingredients found in nature.” California Naturel conceded that its “all natural” sunscreen actually contained the synthetic ingredient dimethicone—making up 8% of the sunscreen formula. The FTC found that was sufficient to find the “all natural” claim deceptive in violation of Sections 5 and 12 of the FTC Act.


Continue Reading The FTC Weighs in Further on All Natural Claims

orange splashWhen courts decide to stay actions to await FDA guidance in an area, it’s only natural that our ears perk up. Which has been going on a lot, with cases such as Kane v. Chobani and Swearingen v. Santa Cruz Natural, Inc.

Last week, however, the Ninth Circuit Court of Appeals, which had previously opted to wait for FDA guidance with respect to evaporated cane juice, decided there was no need to wait for FDA to provide further guidance on “natural” claims in Brazil vs. Dole. In 2013, the lower court had granted in part, and denied in part, Dole’s motion to dismiss or strike the first amended complaint. (More about the significance of the 2013 date below.) The Ninth Circuit found that a decision not to stay or dismiss the case under the doctrine of primary jurisdiction was not an abuse of discretion.


Continue Reading Ninth Circuit Decides Not To Stay Natural Case, But Read the Fine Print