Posted 17 April 2015
This article not only points out that the claims for, and the scam product Green coffee bean extract is still available in Canada, in spite of a landmark retraction, but how deficient the Canadian regulatory authority in controlling these products are. Health Canada’s regulation of CAMS is often given as an example of how well CAMS can be regulated when in fact their approach is shown to have little protection for consumers.
“At issue is a tiered approval process that Health Canada calls a “risk-based approach to safety and efficacy.” Under this system, the level of evidence required to approve a product can vary depending on the specific health claims and the perceived level of risk. So low-risk products require little hard evidence to be approved.”
“Williams calls this “risk-based” approach ridiculous. “We have a regulatory framework, but the tendency is toward rubber-stamping, toward bending over backwards to make things easier for industry rather than safer for consumers,” he says. “It’s not that useful, what we have.”
Read the article at the National Post
The article is reproduced here in the event the original is offline. Best to view the original for it has hyperlinks and image.
Despite a landmark retraction, the Dr. Oz-promoted Green coffee bean extract still on Canadian shelves
Christoper Labos, Special to National Post | April 8, 2015
When health guru Dr. Mehmet Oz recommends a natural remedy on his hugely popular TV show, it’s a safe bet that thousands of viewers will rush out to buy it. But it turns out that Canadian regulators are much slower to respond when a product fails to live up to Oz’s oft-spectacular claims.
In 2012, Oz promoted green coffee bean extract as a way to lose weight and called upon “celebrity nutritionist” Dr. Lindsey Duncan as an expert to discuss this new scientific research. Duncan, who also sold and marketed the product, subsequently netted millions in in sales as a result of his TV appearances. But things unraveled quickly and within two years, the research touted by Oz and Duncan was discredited and retracted. In October 2014, the Texas attorney general filed charges against Duncan alleging that his degree is fake and invalid. And in January, the Federal Trade Commission accused Duncan of false advertising and using the Dr. Oz show to maximize his “ill-gotten gains.”
Green coffee bean extract continues to be promoted in both the U.S. and Canada and is freely available at Canadian health food stores. Indeed, Health Canada has no authority to remove it from store shelves even if it wants to.
Dr. Joe Schwarcz, professor of chemistry at McGill University in Montreal, worries that Canadians do not fully appreciate how little evidence is required to back up the medical claims of some natural-health products.
“The Natural Health and Non-Prescription Health Product Directorate is a national shame,” Dr. Schwarcz says of the division of Health Canada that regulates natural health products. “It’s a type of negligence, because it gives the wrong impression to the public that these things are proven to be safe and effective, which is not the case.”
Green coffee bean extract is just one of the products Oz has touted over the years for its slimming properties. Previous Oz favourites have including acai berry, raspberry ketone and the tropical fruit garcinia cambogia.
Green coffee beans are coffee beans that have not been roasted. They contain chlorogenic acid, an antioxidant that is mainly lost during the roasting process, and is supposed to help with burning fat, weight loss, glucose metabolism and blood pressure. Oz began recommending them after the publication of a study funded by the manufacturer Applied Food Sciences Inc. The study, conducted in India in 2010, randomly assigned 16 people to high-dose extract, low-dose extract, or a placebo.
As Oz described it on his eponymous television show, green coffee bean extract was a “miracle in a bottle” that would “bust fat.” He cited a “staggering, newly released study.” Two years after he made those claims, the study was retracted and Applied Food Sciences agreed to a settlement with the U.S. Federal Trade Commission.
The complaint filed by the FTC in 2014 alleged that “the study was so hopelessly flawed that no reliable conclusions could be drawn from it.” The FTC claimed that the lead researchers had manipulated the data. For example, they changed the trial’s duration, altered the weights of some study subjects and mislabelled the subjects who received a placebo and those who received the extract.
Jessica Rich, director of the FTC’s Bureau of Consumer Protection, called it a “botched study” that had “helped fuel the green coffee bean phenomenon.” Under the settlement, the company paid US$3.5-million and agreed to pull ads claiming that the product led to “substantial weight and fat loss.”
On Jan. 26, the FTC also reached a settlement with Duncan for US$9-million. The FTC alleged that Duncan accepted an invitation to the Oz show, even though he had never studied green coffee bean extract before, and quickly arranged for his companies, Genesis Today and Pure Health LLC, to start selling the product. This came just months after court filings in Texas revealed that Duncan’s degree came from Clayton College of Natural Health, a non-accredited distance learning school in Alabama. The school is specifically named on Texas Higher Education Coordinating Board’s list of “Institutions Whose Degrees are Illegal to Use in Texas.”
Since then, Oz has distanced himself from the study and the product. His website now acknowledges the retraction with a posted statement: “Further study is needed regarding any potential benefits of Green Coffee Extract.” (Neither the Dr. Oz Show nor Applied Food Sciences responded to multiple requests for an interview from the Post.)
The response in Canada has been far more timid. Health Canada has a completely different approach to the regulation of natural health products. Unlike most countries, Canada has set up a process specifically to evaluate natural health products. Health Canada’s Natural Health and Non-Prescription Health Products Directorate has a mandate to check whether natural health products are safe and effective.
In this respect, Canada is ahead of the curve, according to Jamie Williams, executive director of Bad Science Watch, a consumer protection and science advocacy organization. But, Williams says, “the approval process is laughable for the vast majority of products.”
At issue is a tiered approval process that Health Canada calls a “risk-based approach to safety and efficacy.” Under this system, the level of evidence required to approve a product can vary depending on the specific health claims and the perceived level of risk. So low-risk products require little hard evidence to be approved.
Williams calls this “risk-based” approach ridiculous. “We have a regulatory framework, but the tendency is toward rubber-stamping, toward bending over backwards to make things easier for industry rather than safer for consumers,” he says. “It’s not that useful, what we have.”
However, Adam Gibson, director-general of the Natural and Non-Prescription Health Products Directorate, the regulating authority for natural health products for sale in Canada, says that is a bit of misrepresentation. “It is a risk-based system,” he says, “but we’re not a leaky bucket. There’s no compromise on safety and there’s no compromise on the quality of products.” He also explains that approval depends on what the product label actually claims. For example, “if it contains anti-oxidants we approve it, but if they claim it cures cancer and all it contains is anti-oxidants, then we refuse it.”
But minor label changes can make a big difference. Using words such as “treat,” “prevent” or “cure” on the label requires strong evidence before approval. But replacing them with words such as “support,” “maintain,” or “provide” puts a lower burden of proof on the manufacturer. Change those words to “helps to,” “source of,” or “herbal use” and companies require even less evidence before approval.
For example, Health Canada’s database lists 10 products containing green coffee extract. Three make no claim for weight loss. Four others say on their labels: “Helps the body to metabolize carbohydrates and fats.” The remaining three claim that they “could be a complement to a healthy lifestyle that incorporates a calorie-reduced diet and regular physical activity for individuals involved in a weight-management program.” By using key words and by not explicitly claiming that a product can help consumers lose weight, less rigorous evidence is required before approval.
Gibson says that for weight loss products in particular there is a lot of exaggeration of benefit. Health Canada has received four complaints of misleading advertising related to green coffee bean extract. The department asked for the ads to be changed, but the products remain on sale. In response, Health Canada has set up a website to clarify the misconceptions and explain what the product labels and health claims mean. “There is no magic bullet,” Gibson says, adding that no product is authorized explicitly for weight loss in the absence of diet and physical activity.
Dr. Mehmet Oz
The current regulations have a number of other loopholes. Traditional and homeopathic products do not need any evidence of effectiveness. Instead, the manufacturer needs to simply provide proof of a long history of use. In its guidelines, Health Canada provides the following example of what is permitted: “used in the time of King Edward II to alleviate coughs.” (King Edward II ruled England from 1307 to 1327.)
The upshot is that the manufacturer does not have to prove that the product actually alleviates coughs, only that it has been used in the distant past for that purpose. The guidelines also explicitly state: “Efficacy should be based on the belief systems, theories, and/or experiences specific to the relevant traditional healing paradigm, not on modern evidence.”
Green coffee bean extract is still widely available in health food stores across Canada, such as GNC, Popeye’s Supplements, Noah’s Natural Foods, the Vitamin Shoppe, and from their websites.
None of these chains responded to requests for comment from the Post. However, in a statement, the Canadian Health Food Association played down the importance of the FTC settlement. It said, “a retraction does not tell us anything about the effectiveness or safety of the treatment.” The association says there is a “wider body of research to support various health claims [about green coffee bean extract].”
Dr. Yoni Freedhoff, an obesity expert at the University of Ottawa, counters that this “wider body of research” does not exist. He says, “green coffee beans should be sold in coffee shops. If you’re taking them to lose weight, you’re just pouring money down the drain.”
Dr. Schwarcz of McGill adds that green coffee bean extract is “just a non-story — Oz just hyped it ridiculously.”
No matter how flimsy the evidence on the extract’s slimming properties, Health Canada has no authority to issue a mandatory recall. Under Bill C-17, which became law in November 2014, the department has new powers to recall dangerous prescription medications. But natural health products are exempt from the legislation, and Health Canada cannot issue mandatory recalls on these products. However, Gibson says it is rare that you would ever have to force a recall and that there a number of regulatory steps that could be used before that becomes necessary.
Nevertheless, exactly that problem occurred in 2013, when the B.C.-based Sequal Naturals refused to comply with a Health Canada request to recall its Vega One nutritional shakes after the discovery that the product was contaminated with the prescription antibiotic chloramphenicol. The company initially rejected Health Canada’s claim that the antibiotic, which can suppress bone marrow, posed any threat to consumers. It agreed to a voluntary recall only after mounting public pressure.
Freedhoff says that Health Canada’s current policy toward natural health products “does a disservice to the health of Canadians, doesn’t protect Canadians, puts Canadians at risk and steals their money.”
Williams takes a more fatalistic view. “Green coffee bean extract is just one in an endless chain,” he says. “It was around before this promotion by Dr. Oz and it will be sold for all eternity probably with exactly the same claims being made.”