Eliminating barriers to DTC advertising for OTCs and natural health products
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* Wayne Kondro

Health Canada has proposed eliminating statutory barriers against direct-to-consumer (DTC) advertising of the purported health benefits from using natural health products (NHPs) and non-prescription drugs to treat serious diseases like cancer.

![Figure1](http://www.cmaj.ca/https://www.cmaj.ca/content/cmaj/174/11/1547/F1.medium.gif)

[Figure1](http://www.cmaj.ca/content/174/11/1547/F1)

Figure. Echinacea, indiginous to North America, is a commonly used natural health product. Photo by: CP Images/TH Foto-Wernbung

Proponents of the change claim it will have little impact other than an occasional advertisement for a very limited number of products, like the use of sunscreens to prevent skin cancer. But critics say it will launch a wave of misleading advertisements that will prey on the desperation of patients.

At issue are regulatory amendments published in *Canada Gazette* last November that will allow manufacturers of NHPs and over-the-counter drugs (OTCs) to make marketing claims of relief in 40 designated diseases and health conditions. 

Since 1934, under regulations designed to prevent fraud, such claims have been prohibited under Schedule A of the Food and Drugs Act.

But Health Canada is proposing to allow health relief claims if they are consistent with the product monograph. Therein, however, lies the rub. The new licensing regime governing NHPs and non-prescription drugs allows manufacturers to make claims of therapeutic benefit based on “traditional” or extended use, which critics say results in products being approved even though their therapeutic efficacy hasn't been scientifically established (*CMAJ* 2005;172[8]:983).

Health Canada is conducting a second round of consultations. The deadline for submissions is May 31.

Many stakeholders believe the regulations “need to be modernized, one, to reflect scientific and medical advances, and two, to reflect the current health care context, which includes the prescription drug regime, pre-market review, universal health care, and the desire of the Canadian public to make decisions about their health care,” says Health Canada spokesperson Christopher Williams.

That rationale mystifies critics, like Dr. Lloyd Oppel, Vancouver-based emergency physician and UBC professor of statistics and experimental design, who argue the change will yield no public health benefits and may even lead to dire forms of mistreatment.

“There are a number of risks,” Oppel says. “One, it may misinform people about matters to do with their health. ... It may cause people to believe they can treat these illnesses by themselves and cause delays in treatment. Or it may give people the impression the purveyors of these remedies are bonafide health professionals. In a sense, it may give credit where it's not due and it may divert from proper care and delay diagnosis.”

Patients suffering from serious Schedule A diseases are “much more vulnerable” and potential harm through mistreatment is much greater, adds Barbara Mintzes, faculty associate with UBC's Centre for Health Services and Policy Research. “One of the risks would have to do with people substituting treatments for which there's less evidence of effectiveness for others, in which there's more evidence.”

If patients aren't informed that the basis of a health claim is something as nebulous as traditional use, the potential for misleading advertising is even greater, Mintzes adds. “And what about a situation where you have a remedy that actually has been tried in a clinical trial and been found to be ineffective? As long as it was approved for that indication, it could still be advertised for it.”

Consumer surveys indicate the mere act of licensing a product legitimizes it as a therapy, even though the scientific evidence of its efficacy or safety hasn't been properly established, argues Bill Jeffery, national co-ordinator of the Canadian Centre for Science in the Public Interest. “In the case of NHPs, the market authorization is often granted on the basis of skimpy to no evidence. . . . In some cases, it really amounts to no more than cataloguing medical lore.” But Non-prescription Drug Manufacturers' Association President David Skinner argues it is unfair to preclude manufacturers from advertising information that's allowed on product labels.

The NHPs and OTCs met a “scientific test” when licensed by Health Canada, and manufacturers should be able to communicate that to consumers, Skinner says. “If you can provide the evidence that supports such a claim in a product that's appropriate for self-care, you should be allowed to do so.”

Skinner also argues there's a public health benefit to such advertising. “If we are preventing people from being able to have access to products with labels that can describe what the product can be usefully used for, we're not doing the health system any favours whatsoever and it defies simple regulatory logic, let alone good science.”

Skinner projects such advertising will be more in the vein of a trickle than a flood. “But if there are more products that are helping consumers to help themselves and keep them out of hospitals and so on, good.”

Although Skinner dismisses the concern as unwarranted, Mintzes believes oversight of NHP and OTC advertising will be inadequate. She says a Health Canada review of non-Schedule A advertising of NHPs indicated that a majority of print ads and roughly one-third of broadcast ads presented inaccurate information.

But Health Canada says revised advertising guidelines (now in consultation phase) will establish that marketing claims must be consistent with evidence presented during a product's licensing stage.

“It has to be based on the Health Canada market authorization,” says Ann Sztuke-Fournier, manager of Marketed Health Products Directorate's regulatory advertising and risk communications section.

“That's a roof built on a house of cards,” Jeffery counters. “The adequacy of evidence accepted by Health Canada to approve health claims is so low the guidelines are doomed to fail public health.”

Oversight of NHP and OTC advertising will continue to be vested with the not-for-profit industry body, Advertising Standards Canada, which will evaluate all ads before they can be shown to consumers.