New York, NY – Nov. 13, 2013 – A five-member panel of the National Advertising Review Board (NARB) has determined that that Meda Consumer Healthcare, Inc., maker of the dietary supplement “MidNite PM,” can support claims that the product lets users “wake without grogginess,” and allows for “faster” sleep.

The NARB panel recommended, however, that Meda discontinue claims related to pain management or “fast” sleep.

NARB is the appellate unit of the advertising industry’s system of self-regulation.
Meda had defended its advertising before the National Advertising Division, an investigative unit of the advertising industry’s system of self-regulation. NAD found that Meda provided a reasonable basis for a claim that melatonin, the primary ingredient in MidNite, “promotes healthy sleep,” as well as claims that the product was “Drug free, not habit forming” and “America’s #1 Natural Sleep Remedy.”

However, NAD recommended that Meda modify its claim “Get to sleep fast, and wake without grogginess” to make it clear that melatonin may help improve sleep when taken regularly and avoid implying that sleep improvement will be achieved by taking a first or one-time dose before bedtime. NAD also determined that Meda did not provide a reasonable basis to support its claim that MidNite can be used to manage minor or occasional pain. The NAD recommended that these claims be discontinued.

Meda appealed NAD’s adverse finding to NARB.

Meda argued before the NARB panel that that the studies it submitted showed that a one-time dose of melatonin is effective in promoting faster sleep. Meda also disputed the NAD’s conclusion that the meta-analysis of melatonin studies showed that melatonin is effective in promoting faster sleep only when taken regularly.

Based on the totality of scientific evidence submitted by Meda, the NARB panel determined that Meda provided a reasonable basis to support its “wake without grogginess” claim.

Further, the panel determined that Meda could support claims that a 1.5 mg or 3.0 mg dose of melatonin can promote “faster” sleep.

However, the panel found that Meda did not provide a reasonable basis for claims that melatonin can promote “fast” sleep. The promise of getting to sleep “fast” reasonably conveys a message that sleep will come instantaneously or very quickly, the panel noted, and the record in this case does not provide reasonable support for that claim.

The panel agrees with the NAD that the support offered by Meda for a claim that the bromelain in MidNite effectively manages minor or occasional pain does not rise to the level of competent and reliable scientific evidence and recommended Meda discontinue such claims.

Finally, the panel noted in its decision that “the most reliable form of substantiation for supplement efficacy claims requires testing of the product itself, and the panel urges Meda and other manufacturers to consider such testing. Without testing of the MidNite product, the advertiser must ensure that any claims based on the efficacy of melatonin do not imply that the MidNite product has been tested.”

Meda, in its advertiser’s statement, said the company is pleased that the NARB panel found “that Meda had provided reasonable substantiation that a one-time 1.5 or 3.0 mg dose of melatonin can promote faster sleep and for the ‘Wake without grogginess’ claim. Meda will take the full findings of the Panel into account as it fashions its future advertising and appreciates the opportunity to participate in the self-regulatory process.”