Following a challenge by Johnson & Johnson Consumer Inc., the National Advertising Division (NAD) has recommended that Wink Naturals LLC discontinue certain challenged claims in online and social media advertising for its Kids Sleep Drops, Sleep Zen Melts, Kids Sleep Melts and Pure Sleep & Breath Chest Rub.
 
NAD is an investigative unit of the advertising industry’s system of self-regulation and is a division of the BBBNP’s self-regulatory and dispute resolution programs.
 
The claims challenged by J&J included, but were not limited to:
 

• Sublingual absorption claims, such as “Melatonin is best absorbed sublingually and our tablets and drops allow for the best absorption and efficacy...” and “What makes our sleep melts better than gummy melatonin or melatonin from other manufacturers? Rapid absorbing means it works faster…”
• “Specifically dosed for children”/“Appropriately dosed for children” (for the Kids Sleep Melts/Kids Sleep Drops products only)
• Highest quality claims, such as “Our melts are made with the highest quality melatonin and other natural ingredients” and “Our proprietary blend of Melatonin, L-Theanine, Xylitol and other natural ingredients combined with our quality manufacturing make for a safe, effective and natural sleep aid you can trust.”
• “Doctor recommended for children and teens 3+” (for the Kids Sleep Melts/Kids Sleep Drops products only)
• “Helps to improve your child’s school performance: A good night sleep can lead to more energy, focus, concentration, information retention and creative problem solving” (for the Kids Sleep Melts/Kids Sleep Drops products only)
• Decongestant claims for Pure Sleep & Breath Chest Rub, such as “Natural decongestant” and “Our natural formula contains safely diluted amounts of eucalyptus oils to open airways and lavender to calm and soothe.”
• “Chest Rub can be used...for sleep training.”
• Sleep aid testimonials for Pure Sleep & Breath Chest Rub, such as “I absolutely love this chest rub for infants, all the way to my toddler! It’s soothing when the kids are congested and helps them sleep through the night...”
• Implied claims that Sleep Zen Melts, Kids Sleep Melts and Kids Sleep Drops are superior to all other melatonin products on the market.
• Implied claim for Pure Sleep & Breath Chest Rub that it is an all-natural alternative and just as effective as OTC drugs in relieving congestion, coughs and pain.
• Implied claim for Pure Sleep & Breath Chest Rub that it is more effective than all other products because it does more than soothe babies and children, it is an all-in-one decongestant, pain reliever and sleep aid.

 
The Kids Sleep Drops are liquid dietary supplements whose main ingredient is melatonin. The Sleep Zen Melts (for adults) and Kids Sleep Melts are also dietary supplements, with the children’s version containing 1 mg melatonin per serving and the adult’s version containing 3 mg melatonin as well as 100 mg L-Theanine per serving. The Pure Sleep & Breath Chest Rub is a topical rub containing numerous ingredients.
 
The advertiser informed NAD in writing that it permanently discontinued certain claims, including social media or website posts with reference to “sensory sensitivity” or “autism”; efficacy statements referencing relief of earaches and headaches; the claim “Made in the USA”; and references to speed or rate of decongestive action associated with eucalyptus oil. NAD, relying on the advertiser’s representations that the claims have been permanently discontinued, did not review the claims on their merits. However, the voluntarily discontinued claims will be treated, for compliance purposes, as though NAD recommended their discontinuance and the advertiser agreed to comply.
 
Turning to the remaining challenged claims, NAD first considered the claims made in connection with Wink’s melatonin sleep products.
 
NAD recommended that the advertiser discontinue the claims, “[H]igh-quality melatonin that is subliminally absorbable can balance these levels.”; “Melatonin is best absorbed sublingually and our tablets and drops allow for the best absorption and efficacy…”; “Begins absorbing through the tongue immediately.” and “What makes our sleep melts better than gummy melatonin or melatonin from other manufacturers? Rapid absorbing means it works faster…” NAD determined that even though the advertiser represented that it would modify its advertising to reference “transmucosal” absorption rather than “sublingual,” the claims convey the message that the Wink products are superior in efficacy and speed of action due to the transmucosal method of administration. NAD was concerned that the studies referenced by Wink in support of its claims differed significantly from the advertiser’s product in dosage, formulation and route of administration and ultimately, NAD was unclear whether the transmucosal method of administration was at all relevant to the advertiser’s product.
 
The advertiser agreed to discontinue claims that the product was “specifically dosed for children” and instead state that the product was “appropriately dosed for children.” NAD noted that within the context of the advertising, which encourages repeated and consistent use of the melatonin sleep products, the claim “appropriately dosed for children” implied a long-term safety message unsupported by the evidence in the record and recommended that the claim be discontinued.
 
NAD determined that the particular context in which the “highest quality” claims are presented reasonably conveys to consumers that due to the specified attributes, Wink’s ingredients are superior to other products in a meaningful way – an objectively provable claim. The advertiser did not provide NAD with evidence supporting its products’ superiority and therefore, NAD recommended that the advertiser discontinue the claim “highest quality ingredients.”
 
Further, NAD recommended that the advertiser discontinue its claim “doctor recommended for children and teens 3+,” because Wink did not submit a reliable survey that demonstrated that doctors recommend Wink Sleep Products as part of their ordinary practice.
 
NAD also determined that it was appropriate for the advertiser to modify its claim “Helps to improve your child’s school performance: A good night sleep can lead to more energy, focus, concentration, information retention and creative problem solving” to more clearly state that Wink’s sleep products aid sleeping and separately, that sleep is beneficial.
 
Next, NAD considered the claims made in connection with Wink’s chest rub sleep product.
 
NAD determined that the advertiser provided a reasonable basis for claiming that eucalyptus is a natural decongestant. However, Wink’s decongestant claims are fashioned as product claims, conveying that there is testing supporting its chest rub’s efficacy as a decongestant. In particular, NAD was concerned with the advertiser’s failure to provide: the quantity of each ingredient in its formula; evidence as to how these ingredients interact or evidence demonstrating that there is sufficient eucalyptus in its chest rub product to act as an effective decongestant. Therefore, NAD recommended that the advertiser discontinue the claims, “Natural decongestant.”; “Our natural formula contains safely diluted amounts of eucalyptus oils to open airways and lavender to calm and soothe.”; “Chest Rub can be used for decongesting…” and “Apply to the chest and neck area just before bedtime to relax, rest and breathe free.”
 
NAD recommended that the advertiser discontinue the claim “Chest Rub can be used…for sleep training” because the advertiser did not provide any evidence demonstrating that the Wink Chest Rub sleep product was an effective aid for sleep training.
 
Finally, because NAD determined that the advertiser did not provide a reasonable basis to support claims that its product is an effective decongestant, NAD recommended that the advertiser discontinue the portions of the challenged testimonials that reference the product’s decongestant properties.
 
In its advertiser’s statement, Wink Naturals stated that it “intends to comply with the recommendations of NAD” and that it “has voluntarily made a number of modifications to its advertising to avoid any misunderstandings.”