The regulations – Bill C-51 in Canada, FDA’s GMPs in the US, and the European health products policy – have “striking similarities in (their) strategies to restrict access to natural health products and truthful claims about them,” they said.
The comments were made at a conference held in Toronto last week, with participants including the Alliance for Natural Health (Europe/international), the Natural Health Product Protection Association (Canada), the Canadian Natural Health Coalition, American Association for Health Freedom (US) and Truehope (Canada).
Concerns
Following consensus on the concerns and challenges facing the industry, an international task force was set up, with a mandate to “intervene strategically to preserve the public’s right and access to natural health, including vitamin and mineral supplements, traditional herbal medicines and the healing arts”.
According to the participants, the task force is necessary because regulators are “exceeding their legal authority” and “ignoring court rulings”.
They are also “overstating and skewing” the human health risks associated with the use of natural health products, “discriminating” against traditional medicinal cultures and “censoring” truthful health information, they claim.
Regulations
Amendments to Canada’s Food and Drugs Act (Bill C-51) have already drawn concern and criticism from industry.
The bill is said to make it more difficult for dietary supplements to achieve natural health product status by subjecting them to costly pharma-style registration procedures. It also threatens to increase penalties for transgressors.
Canada’s Health Food Association (CHFA), a trade group for natural and organic products, has said the bill “views natural health products through the lens of pharmaceutical drugs and that is just not right for consumers."
In the US, the Food and Drug Administration’s Good Manufacturing Practices (GMP) legislation, implemented last year, is set to provide standards for safety and legality in supplement manufacturing.
As well as checking for sanitary and consistent products, the new GMPs also ensure purity, identity and strength of composition. The rules, which started being phased in this year, put the burden solely on the manufacturer.
In Europe, new health claim regulations mean stringent requirements must be met for any health claim to be approved. The first round of health claim assessments, which came through last month, saw a string of rejections that signal a hard line methodology.
Quality
However, despite the challenges industry faces, there is a strong voice in favor of these regulations.
Many industry members consider them to be crucial for maintaining product quality and integrity, and ultimately promoting and protecting the supplements sector.
Daniel Fabricant, vice president of scientific and regulatory affairs at the trade groupNatural Products Association highlighted the importance of “fair and strong regulations”.
“I don’t think the GMPs are restrictive. It’s something industry asked for, it’s really an important part of demonstrating quality,” he told NutraIngredients-USA.com this morning.
“We have to be responsible. That really becomes the more important issue,” he said.