Not evaluated by the FDA

Due to some scheduling freedom, I’ve lately become a bit nocturnal, and I’ve found myself watching a lot of late-night/early-morning TV. This has given me the opportunity to reflect on the ridiculous ads that companies save until we are maximally sleep-deprived and hopefully stupid enough to believe the crap that they are shoveling. Frankly, it is unbelievable.

I wanted to write something all about Dr. Frank’s No Pain Spray, because I’ve seen about nine zillion commercials for that. But once you get over the fact that it’s an oral spray that looks like a breath freshener but that’s supposed to provide all the way up to post-surgery level pain relief (no, I’ll take the Percocet, please), the fact that it claims not one but ten different homeopathic ingredients (slightly increasing the probability that a single non-water molecule might exist in the spray), and the fact that it’s only advertised at 3 AM (not a good sign for credibility), there’s really not a lot more to mock. Borrr-ing. Besides, someone else has done it more thoroughly than I would care to.

However, I think it’s important to say something about a more general problem I have with this class of advertisements. All these diet pills, “male enhancement” tablets, and so on make their claims of widespread success, then display the tiny text: “This product has not been evaluated by the FDA.” Is that enough to meet our legal standard for truth in advertising?

The Federal Trade Commission has this very clear FAQ about false advertising on their website. In particular I think it’s worth highlighting this one.

What makes an advertisement deceptive?
According to the FTC’s Deception Policy Statement, an ad is deceptive if it contains a statement – or omits information – that:

— Is likely to mislead consumers acting reasonably under the circumstances; and
— Is “material” – that is, important to a consumer’s decision to buy or use the product.

It goes on to explain the process the FTC uses to investigate claims of false advertising, and uses the particular example of a mouthwash that claims to prevent colds. The FTC looks from the point of view of a “reasonable consumer” and evaluates both “express and implied claims,” checking to see if the advertiser has enough proof to back them up. In the particular example of medical or other scientific claims, the advertiser is expected to have “competent and reliable scientific evidence.”

I also found a page on the FTC’s website called Dietary Supplements: An Advertising Guide for Industry. It has a lot of important and relevant information, and in particular in section II.C.3 mentions the Dietary Supplement Health and Education Act (DSHEA) disclaimer, “that the statement has not been evaluated by FDA and that the product is not intended to ‘diagnose, treat, cure or prevent any disease.’” DSHEA doesn’t explicitly apply to advertisements, but this document does say that it’s a good idea to include the disclaimer “to prevent consumers from being misled about the nature of the product and the extent to which its efficacy and safety have been reviewed by regulatory authorities.” I was glad to see this example used to illustrate the issue:

Example 34: An advertisement for an herbal supplement includes strong, unqualified claims that the product will effectively treat or prevent diabetes, heart disease, and various circulatory ailments. The advertiser does not have adequate substantiation for this claim, but includes the DSHEA disclaimer prominently in the ad. In face of the strong contradictory message in the ad, the inclusion of the DSHEA disclaimer is not likely to negate the explicit disease claims made in the ad, and will not cure the fact that the claims are not substantiated.

This is a good standard to have. There are two prongs to the DSHEA disclaimer; I’ve usually only seen the first half used (in small and hard-to-read print, no less). The second half, that the product is not intended to provide any actual medical service, would seem ridiculous when compared to the explicit claims of medical service made over and over again in the ad. Of course it’s intended to diagnose, treat, prevent, or cure something! The first half of the disclaimer, though, is even less effective at offsetting the false advertising. The lies may not have been evaluated by a regulatory agency, but that doesn’t make it okay to lie. It’s the advertiser’s job to make sure what’s in the ads is true, and this feeble attempt to displace blame is laughable.

The problem, then, is not that we don’t have a good standard delineating what’s false advertising, bur rather that the standard is not being enforced. These advertisements aren’t just stupid, they’re nefarious — they’re lies told only when viewers are expected to be at their weakest emotionally and blurriest rationally.The FTC needs to step it up and get these cranks off the air.

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Comments

2 Responses to “Not evaluated by the FDA”

  1. Wavatar It’s the Thought that Counts » Blog Archive » GAO on DSHEA on March 12th, 2009 10:38 pm

    [...] Sorry about the acronyms; just wanted to keep things brief and to-the-point. The Government Accountability Office (GAO) released a report [PDF] recommending increased oversight of dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) has allowed many pseudoscientific products to hide their fraud behind a disclaimer. I’ve discussed this issue here before. [...]

  2. Wavatar metal321 on May 11th, 2009 5:00 am

    I’ve been watching those stupid pain spray commercials for a long time wondering how the hell I could get them off the air. My girlfriend has arthritis and I know what a sucker she can be for any kind of “alternative medicine”. It makes my blood boil seeing these lowlifes making money off of the weakest members of our society. I don’t see how what they are doing can be legal. They make outright claims in their commercials that it can relieve pain. And anybody who knows anything, knows that this homeopathic product couldn’t possibly relieve pain. I wrote to one of the agencies and they referred me to another one. I can’t remember if I tried the FTC. I thought it was the FTC, but maybe they were the agency I was referred to, but I never went any further, because it just seemed hopeless trying to get the government to act. If anyone has any advice, I’d like to hear it. I want to see these bloodsuckers off the air ASAP.

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