MidNite PM “Sleep Fast” And Pain Relief Claims Unsubstantiated – NAD

Meda Consumer Healthcare appeals a NAD decision to the National Advertising Review Board. Meda’s evidence failed to show whether its proprietary blend or the individual ingredients provide MidNite PM’s benefits, NAD says, and stating that each ingredient has “calming properties” is “insufficient to support the claim.”

[Meda Consumer Healthcare Inc.] did not rest after the National Advertising Division found the firm failed to support claims that its MidNite PM melatonin supplement works at first use to improve sleep and help relieve minor pains.

The subsidiary of Swiss firm Meda AB is appealing the decision to the Council of Better Business Bureaus’ National Advertising Review Board, NAD said June 18.

In its ongoing review of dietary supplement advertising financed partly by the Council for Responsible Nutrition, NAD found that Meda Consumer supported claims that MidNite PM is “America’s #1 Natural Sleep Remedy” but recommended the firm “continually monitor sales data to ensure that this claim remains accurate,” according to a case report completed May 31.

Meda also supported the claim that the product, a proprietary blend of melatonin with chamomile, lavender, lemon balm and bromelain – an extract from pineapple stems – is “drug free, not habit forming,” NAD said.

However, NAD recommended Meda discontinue these claims for MidNite PM:

• “Get to sleep fast, and wake without grogginess”
• “The only one you can take before bed or in the middle of the night”
• “The only one you can take when pain keeps you up or wakes you in the night”
• “The only one you can take any time of night to relieve occasional pain, help you sleep & wake alert!”

According to the case report, Meda lacked clinical data to demonstrate whether its proprietary blend or the individual ingredients provide the claimed sleep-related benefits. Meda’s statement, with no research cited, that each ingredient is known to have “calming properties” is “insufficient to support the claim,” NAD said.

The CBBB division’s attorneys reviewing Meda’s information found a reasonable basis for a claim that the melatonin in the product “promotes healthy sleep,” but recommended the firm modify the claim “get to sleep fast, and wake without grogginess.” The attorneys said Meda should “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.”

Atypical Studies Rejected

Meda submitted multiple melatonin studies to support those claims. But NAD pointed out two of the studies Meda cited kept subjects in sound-attenuated rooms in near darkness for 16 hours a day with food provided every two hours, conditions that do “not reflect a typical day for most consumers.”

NAD attorneys also found “limited value” in the bromelain studies Meda submitted to support the “manages minor pain” and “occasional pain” claims. One study, which was reviewed in a prior NAD case, was insufficiently reliable to support a joint health claim, “and the authors … concluded that the results warranted conducting a double-blind, placebo-controlled study,” NAD said.

NAD also said none of the studies were directly relevant or supportive of the claims and some:

• consisted of daytime use of melatonin supplements, though MidNite PM is intended to be taken before sleep or during the night
• failed to use a relevant test population of general consumers but included subjects such as elderly patients who suffered from insomnia, individuals with Rett syndrome neurodevelopment disorder and night-shift nurses
• had methodological flaws, such as “very small” sample sizes, testing only male subjects or using lower doses of melatonin at intervals earlier or more frequently than MidNite PM instructions indicate.

NAD also said Meda failed to support exclusivity claims, saying the claims with the phrase “only one” reasonably communicate a message of exclusivity.

Meda explained when NAD began the review that the firm acquired the MidNite PM line in 2012 and is updating the product’s marketing plan, including revising the claim “the only one you can take before bed or in the middle of the night” to emphasize that the product can be taken at the beginning or middle of the night safely and effectively (Also see "In Brief" - Pink Sheet, 10 Dec, 2012.).

However, Meda did not prove that MidNite PM “is the only sleep aid that can be taken before bed or at any time during the night to relieve sleeplessness or occasional/minor pain.” While Meda submitted studies on melatonin and bromelain, ingredient studies are insufficient to support the exclusivity claims and NAD recommended they be discontinued.

Meda also submitted an animal study. “It is well-established, however, that animal studies are insufficient to support product performance claims for products intended for consumption by humans,” NAD noted.

Firms participating in NAD reviews can appeal the division’s decisions to NARB. When firms decline to participate in reviews or do not make changes NAD recommends or the review board upholds, the industry self-regulation organization generally refers the information to the Federal Trade Commission.