New York, NY – June 18, 2013 – The National Advertising Division recommended that Meda Consumer Healthcare, Inc. discontinue certain advertising claims for the company’s “MidNite PM” dietary supplement. NAD found, however, that evidence provided by Meda could support claims that the product is “America’s #1 Natural Sleep Remedy,” based on sales data, and that it is drug free and not habit forming.

Meda said it will appeal certain adverse NAD findings to the National Advertising Review Board.

NAD is an investigative unit of the advertising industry system of self-regulation and is administered by the Council of Better Business Bureaus.

NAD, as part of an initiative with the Council for Responsible Nutrition to expand the review of claims for dietary supplements, requested substantiation for claims made for MidNite PM in Internet and print advertisements and on product packaging.

Claims at issue in NAD’s inquiry included:

•  “The only one you can take before bed or in the middle of the night…”
•  “The Only One You Can Take Any Time of Night To Relieve Occasional Pain, Help You Sleep & Wake Alert!”
•  “MidNite PM: The only one you can take when pain keeps you up or wakes you in the night”
•  “Promotes healthy sleep and manages minor pain.”
•  “Get to sleep fast, and wake without grogginess.*”
•  “America’s #1 Natural Sleep Remedy.”
•  “Drug free, not habit forming.”

MidNite PM contains a proprietary blend of melatonin, chamomile, lavender and lemon balm and the advertiser relied primarily on melatonin studies to support its claims.

However, the advertiser failed to provide any testing on its proprietary blend of ingredients to demonstrate whether this blend works with melatonin to provide the claimed sleep-related benefits. The advertiser also failed to provide any studies concerning the sleep-related benefits on the individual ingredients, except to note that each of the ingredients are known to have “calming properties,” an assertion which, standing alone, is insufficient to support the claim.

Following its review of the evidence in the record, NAD recommended the advertiser discontinue the following claims:

•  “[t]he only one you can take before bed or in the middle of the night….”
•  “The Only One You Can Take Any Time of Night To Relieve Occasional Pain, Help You Sleep & Wake Alert!”
•  “The only one you can take when pain keeps you up or wakes you in the night.”

NAD concluded that the advertiser provided a reasonable basis for a claim that the melatonin in the product “Promotes healthy sleep” but recommended that the claim “Get to sleep fast, and wake without grogginess.*” be modified to make clear that melatonin may help improve sleep when taken over a period of time and avoid implying that sleep improvement will be achieved by taking a first or one-time dose before bedtime.

NAD further concluded that the advertiser provided a reasonable basis for the claims “Drug free, not habit forming” and “America’s #1 Natural Sleep Remedy” but recommended that the advertiser continually monitor sales data to ensure that the “America’ #1 Natural Sleep Remedy” claim remains accurate.

Finally, NAD determined that the advertiser’s evidence, namely studies on the ingredient, bromelain, was not sufficient to support its “manages minor [or “occasional”] pain” claim and recommended that it be discontinued.
Meda, in its advertiser’s statement, said the company “respectfully disagrees with, and will appeal to the National Advertising Review Board, the NAD’s recommendation that Meda modify its ‘Get to sleep fast, and wake without grogginess’ claim to make clear that melatonin may help improve sleep when taken regularly (i.e., when taken over a period of time) and to avoid implying that sleep improvement will be achieved by taking a first or one-time dose before bedtime. Further, Meda will appeal the NAD’s recommendation with respect to ‘manages minor [occasional] pain’ claim.”