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Stephen Ruscus Presents at Pharmaceutical Pricing Boot Camp

So our holiday gift from the FTC, which flew a bit under the radar if you ask us, was the <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Health-Guidance-508.pdf">Health Products Compliance Guide</a>. This was quietly heralded as an update to the 1998 Dietary Supplement Advertising Guides, but oh dear readers, it is so much more. I don’t want to be overly dramatic, but I think it will be the FTC’s 2023 bestseller, cited more often than any other case, rule, or guidance. We shall see. The FTC gives a pithy overview of the new guidelines <a href="https://www.adventures-in-law.com/ftc/ftc-updates-long-standing-health-advertising-guidance-with-lessons-learned-from-the-21st-century/">in this blog</a>. (We also have an upcoming webinar covering the topic in March – <a href="https://bakerlaw.zoom.us/webinar/register/WN_Aj2idWu7RomIM_LoWvY5_g">details here</a>.)



What seems clear is that NAD is reading this document with a fine-tooth comb, and one can expect to see this guidance followed to a tee as far as what is expected from advertisers for all manner of health claim substantiation. I also suspect that use of the guidance will not be limited to dietary supplement cases but will find its way into review of any performance claims for FDA-regulated products, including cosmetics and foods. While this guidance was not directly cited in <a href="https://bbbprograms.org/media-center/dd/oral-essentials">NAD’s most recent case</a>, the principles were closely followed. The short summary is that randomized controlled human clinical trials are expected in most cases to support health claims, and the studies themselves have to carefully link up to the claims they purport to support. If you have a bit more time to spare, apply some whitening strips of your brand of choice and settle back while we dive in.



P&G took issue with a claim by competitor Oral Essentials that its whitening strips were “clinically proven to whiten as well as the leading brand … without the harm.” The full claim is: “Lumineux (pronounced Loo-ma-no) Whitening Strips are the first on the market that are delicious and clinically proven to whiten teeth as well as the leading brand, without the harm associated with bleaches.” Now whitening, unlike cavity protection, is a cosmetics claim, but this is an establishment claim, meaning Oral Essentials said its strips were at parity with those of the big guys and this was “clinically proven.” Here Oral Essentials had not one but two clinical trials, one studying the efficacy of its whitening strips and the other the efficacy of its whitening pen. NAD found these studies supported monadic claims about the efficacy of the Lumineux whitening products. To support the comparative claim, Oral Essentials did a head-to-head in vitro lab test using 40 enamel chips from 20 healthy human extracted teeth (two from each tooth). (Does the Tooth Fairy sell the teeth she collects for such purposes? Hmmmm.) They stained the samples and then applied Lumineux strips and Crest Whitestrips for an hour and compared the results. And did a rinse and repeat 10 times. (In between each “whitening episode” the teeth chips were immersed for one minute in a “saliva solution.” 1. Gross and 2. Why?) Use of a colorimeter to compare the samples showed similar whitening effect.



NAD, however, rejected this study as support for the comparative claim. Why? Well, it was not a human clinical study. The advertiser sought to do something fairly common – bridge the in vitro study to the clinical studies using an expert to explain why the in vitro study results correlate and validate the human clinical studies so the two together can be used to support the comparative claim. NAD did not exactly rule out that this was possible, but it set a very high bar that studies being compared had to be “substantially similar in all material respects.” Additionally, NAD noted the study authors themselves concluded the lab tests were not a substitute for human clinical work. (It is indeed a bummer when your own experts basically talk smack behind your back.) But there is more. The test strips were used for an hour in the in vitro study, whereas the usage instructions said to use them for no more than 30 minutes. Further, the test was designed to evaluate whitening toothpaste and only looked at extrinsic stain removal; it did not include an assessment of intrinsic (or below the surface) stain removal. For all of these reasons, NAD found the comparative parity claim was not supported.



Would NAD have accepted these studies in total to support a comparative cosmetic whitening parity claim if Oral Essentials had not asserted this was “clinically proven?” In my experience, NAD has trended in the last few years toward significantly tightening its requirements for cosmetic claim support, in some cases where it feels like cosmetic claims are almost being treated like drug claims. With the FTC’s new Health Guidance, it will be interesting to see if both the agency and NAD continue to move to a more one-size-fits-all approach. 



Why does this matter? If you promise you have a clinical, you better have a good clinical. For a comparative performance claim, most likely a head-to-head product clinical test will be expected. And for any sort of testing, don’t forget to follow the use instructions so the results are consumer relevant, reflecting how the products are used in the real world. NAD noted in this case that there were 60 clinical trials studying Lumineux products. Friends, it is all about quality, not quantity. One good clinical trial can be enough but getting one good study is tougher than it seems.

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NAD Whitening Strips Case Illuminates How NAD May Incorporate New FTC Health Claims Guidance

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