Please find below the latest edition of our monthly newsletter specifically for our clients marketing dietary supplements. We hope this helps you stay out in front of regulatory challenges.
FTC DEVELOPMENTS
FTC Keeps in Mind Cognitive Function Claims
BY JOHN VILLAFRANCO
On May 18, the FTC announced a settlement with a company that offered cognitive training at its LearningRx centers. The FTC alleged that the company promoted its training programs with claims to raise IQ and therefore raise income; improve performance in school and on standardized tests; improve athletic performance through improved cognition; and treat serious diseases and conditions, including Attention Deficit Disorder, autism, dementia, Alzheimer’s disease, and traumatic brain injury.
The company and an individual officer agreed to pay $200,000 in redress. Four million dollars ($4,000,000) will become due if it is later found that they misrepresented their financial status. Under the settlement order, they must also possess well-controlled clinical testing for any similar brain or cognitive function claims made in the future.
This new settlement shows that the FTC continues to focus heavily on claims to improve cognitive function. Since 2014, the FTC has taken action against cognitive function claims in five cases. From 2000 until 2013, it brought only one action on cognitive function claims.
FTC Gets Testy About Disclosures
The FTC has announced that it will hold a public workshop on the testing of disclosures on September 15, 2016. The FTC hopes that the workshop will “further the understanding of testing and evaluation of both offline and online consumer disclosures, including those delivered through icons, product labels, short text, long text, audio or video messages, interactive tools, and other media.” Topics to be discussed may include “evaluation criteria, testing methodologies, best practices, case studies, and lessons learned from such testing.” The FTC asks prospective presenters to provide a summary of their relevant expertise and what they would like to present. This event is consistent with the FTC’s continuing focus on the adequacy of disclosures.
FDA DEVELOPMENTS
FDA Releases Final Rules Revising Supplement and Nutrition Facts and Certain Serving Sizes; Industry Given Two to Three Years to Comply
BY DONNELLY MCDOWELL
On May 20, FDA announced that it was finalizing two previously proposed rules that will require industry to overhaul Supplement and Nutrition Facts panels on products sold in the United States and recalculate serving sizes for some foods. The new rules mark the first time that FDA has engaged in rulemaking to update the framework for nutrition labeling since 1993. The final rules are largely consistent with the initial proposed rules, which we covered here and here. Notable changes to today’s labels include the following: - A revamped format, which will increase the type size for “Calories,” “servings per container,” and the “Serving Size” declaration.
- The addition of “added sugars” in grams and as a percent Daily Value. Controversially, FDA issued a supplement in July 2015 to the initially proposed rules in March 2014, which proposed to include a percent daily value for added sugars that would not exceed 10 percent of total calories. In finalizing the rule as proposed, FDA rejected comments noting that it has acknowledged that there is no chemical difference between sugars that are added to foods and naturally occurring sugars. FDA cited data that allegedly shows that it is difficult to meet nutrient needs if you consume more than 10 percent of your total daily calories from added sugar.
- The addition of Vitamin D and Potassium as mandatory declarations. Citing food consumption surveys by the CDC, FDA will require vitamin D and potassium to be added to the Facts labels based on perceived deficiencies in the American population. Vitamins A and C will no longer be mandatory declarations, although manufacturers can still list these vitamins voluntarily.
- The addition of Choline and Fluoride to ordered list on Supplement Facts panels. Supplement Facts must list the dietary ingredients that have Daily Values in the same order as for the labels of conventional foods, except that vitamins, minerals and electrolytes are grouped together. This results in the following order for vitamins and minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, and potassium. This list will now include choline after pantothenic acid and fluoride at the end, after potassium.
- Revisions to serving sizes. The final rule revises serving sizes based on more recent food consumption data. For example, the serving size for ice cream is changing from 1/2 cup and 2/3 cup and the serving size of soda is changing from 8 ounces to 12 ounces.
- New definition for dietary fiber. The final rule adopts a new definition for dietary fiber that requires FDA to have made a determination that the substance has physiological effects that are beneficial to human health. The new definition will present a host of legal and logistical issues for manufacturers as they determine how to calculate a particular product’s dietary fiber content.
- New recordkeeping requirements. The rules impose onerous new recordkeeping requirements, which will require manufacturers to make and keep records related to added sugars, certain fibers, vitamin E, folic acid, and folate.
As far as when consumers can expect to start seeing the new labels in stores, it’s not entirely clear. Most companies will have to comply within two years, while small businesses (defined as having less than $10 million in annual sales) will have three years. But at this stage, it’s unclear whether compliance means that all labels with the old format must be off store shelves, or whether only newly manufactured products will need to use the new labels.
FDA will likely continue to issue guidances and other documents designed to help businesses and consumers prepare for implementation of the new regulations. Stay tuned for what is bound to be an interesting process as industry overhauls labels for the first time in over 20 years. | FDA to Chew Over Meaning of “Healthy”
Although “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat. Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it will be re-considering the criteria for “healthy” and similar claims.
In March 2015, KIND, the makers of granola bars, received a warning letter from FDA in part because it labeled certain products as “healthy” even though the products contained more saturated fat than is permitted for a “healthy” claim. KIND changed its labeling, and FDA issued a closeout letter in April 2016. Soon after, KIND requested that FDA confirm it could use “healthy” to describe the company’s corporate philosophy. FDA agreed that using “healthy” in that way is acceptable, because it is not used as a nutrient content claim and does not appear on the same display panel as nutrient content claims or nutrition information.
FDA issued a statement explaining its analysis of the “healthy” claim for KIND’s corporate philosophy and in that statement, it also announced that “now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term ‘healthy.’” FDA cited evolving nutrition research, forthcoming Nutrition Facts labeling final rules, and a citizen petition from KIND for this decision.
FDA plans to solicit public comments on these issues “in the near future.” Through the comment process, companies and organizations with views on the appropriate criteria for “healthy” and other nutrient content claims can help educate FDA and ultimately shape FDA policy. Stakeholders should begin considering their opinions now, to be able to respond when FDA opens its comment period. |
CLASS ACTIONS
“Commonplace” Sense Prevails in Slack Fill Case
In May, the Ninth Circuit ended a slack fill case that had been filed against the sellers of Sugar Lip Treatment lip balms. Plaintiffs alleged that the product packaging and net quantity statements deceived consumers given that dispenser tubes made a portion of the lip balm difficult to reach or use. The Ninth Circuit affirmed the lower court’s dismissal after finding that no reasonable consumer could be deceived under the circumstances. The court reasoned that product labels accurately disclosed the “correct weight of the included lip product” and the “use of a screw mechanism to push up a solid bullet of lip product are commonplace in the market.” The court observed that a “reasonable consumer understands the general mechanics of these dispenser tubes and further understands that some product may be left in the tube to anchor the bullet in place.” Based on this rationale, the court dismissed all claims that were based on California’s deceptive advertising laws and laws specifically on cosmetic labeling. The court further found that the California law on “slack fill” could not apply given that “under the plain language of the statute, slack fill means the portion of the container without product, i.e., empty space.” Lip balm left in tubes is not empty space.
This case could be helpful for dietary supplement makers facing slack fill lawsuits. As we’ve discussed previously, plaintiff’s lawyers have filed numerous slack fill suits over powdered dietary supplement products, including protein powder, weight loss shakes, and powdered vitamin C. State and federal slack fill laws include an exception for empty space that is due to “unavoidable product settling during shipping and handling.” Practical arguments like those used in the lip balm case would no doubt bolster arguments that this exception for “settling” should apply. Like lip balm tubes, opaque tubs used to sell powdered food and supplement products are commonplace. Consumers, thus, likely understand the mechanics of settling powder and never expect such containers to be brimming with powder upon purchase. Arguments like this can help remind courts that slack fill laws seek to prevent not all slack fill, but only slack fill that is misleading.
NAD Cases | NAD Watches Over “StyleWatch” on People.com
BY GONZALO MON
When the FTC issued its guidance on native advertising last year, the Commission emphasized the importance of ensuring that consumers are able to distinguish ads from editorial content. If the line between the two gets blurred, companies may need to label ads as such. Where the label is placed can be critical, because the FTC believes that consumers should know that something is an ad before they interact with it. Last week, the NAD issued a decision that addresses the placement issue.
Joyus is an e-commerce platform for various lifestyle products including fashion, beauty, personal care, fitness, and home products. Many of these products are featured in the “Stuff We Love” section of People magazine, which appears in the Style Watch section of the magazine’s website. Consumers can read a description of each product and watch a video – which is jointly produced by Joyus and People – that advertises the product. If consumers like what they see, they can easily purchase the product on the same screen.
Joyus and People took various steps to separate the magazine’s editorial content from Joyus’ advertising content. For example, the product videos all include the Joyus logo in the upper-left corner of the video player’s frame. This logo – along with a discount offer – can be seen before the video is played, as well as during the entire time the video is played. Joyous argued that these labels clearly let consumers know that the videos were ads, rather than editorial content.
Although the NAD agreed that the videos themselves were clearly labeled as ads, the NAD was concerned that the pages leading up to the videos were less clear. For example, the “Style” page link to “Stuff We Love” doesn’t disclose that the feature is a partnership with Joyus and promotes products for sales. As a result, the NAD opined that consumers could believe these pages represent selections by people’s editors, rather than paid ads. Thus, the NAD recommended that Joyus (in collaboration with People) revise the link so that it is clear that by clicking on the “Stuff We Love” link, a consumer will be taken to a list of items for sale by Joyus.
Although the FTC’s guidance on native ads is helpful, it’s often useful to see “real life” examples. We expect to see more of them from the NAD in the coming months. |
NAD Slashes Weight-Related Claims for Green Tea and Caffeine
BY JOHN VILLAFRANCO
As part of its regular monitoring and its joint initiative with the Council for Responsible Nutrition, the NAD reviewed labeling and advertising claims for Mega-T Green Tea Fat Burning Supplements. The NAD requested substantiation for numerous claims including the following: - “Now Mega-T has an advanced system that combines probiotics with clinically effective green tea to help you achieve your weight loss goals”;
- “Green Tea helps promote ‘good bacteria’ and burn fat”; and
- “Green Tea: Curb appetite and improve fat metabolism.”
The advertiser chose to discontinue most of the claims, which it explained had been used by a prior owner of the Mega-T brand. However, the advertiser defended claims that its product helps consumers “boost metabolism” and “burn fat.”
The NAD held that short-term, “one-day” studies offered by the advertiser failed to support the “broad, unqualified ‘boosts metabolism’ claim.” The NAD noted, however, “that nothing in [the] decision prevents the advertiser from making a carefully tailored claim that more closely matches the evidence in the record, namely the short-term nature of the recorded metabolism benefit.”
The NAD rejected the “burn fat” claim after finding that various meta-analyses reached only tentative conclusions about the potential effects of green tea and caffeine on fat loss. The NAD also noted that many of the positive studies that were offered were conducted in Asia or tested only people who regularly consumed 300 mg or less caffeine per day.
One wonders if, in this case, the NAD sets the bar so high that it deprives consumers of useful dietary information. Under well-settled law, determining whether advertising substantiation is adequate depends on weighing factors such as the type and specificity of the claim, the type of product, and the potential consequences if a claim is false. Such factors would seem to weigh in favor of allowing simple, unadorned “boost metabolism” claims and qualified fat and weight-related claims that are commensurate with the conclusions of the meta-analyses. The NAD, in past cases on green tea and caffeine products, has allowed such claims. Likewise, in many cases, it has allowed simple “boosts energy” claims for caffeine products despite never – to our knowledge – reviewing any long-term studies and despite it being well known that caffeine’s stimulant effects vary widely among different people.
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