Natural Health Products to undergo new regulations
- Details
- Published on Thursday, November 24, 2016
By Miranda Leybourne
Neepawa Banner
Big changes are in the works for how Health Canada regulates self-care products, including cosmetics, natural health products (NHPs) and non-prescription drugs.
The federal government plans to develop new policies and proposals related to the Regulatory Transparency and Openness Framework (RTOF), which includes all the regulations and rules that companies must follow to sell products in this country.
Health Canada will be looking at evaluating and approving rules in regards to what claims can be made about cosmetics, NHPs and non-prescription drugs, how products should be made, labelled and packaged, how safety and compliance will be monitored once products hit the shelves and the consequences for companies who do not follow the rules.
The new structure that Health Canada is considering for classifying self-care products would be based on risk. Lower risk products, including cosmetics, vitamins and minerals, toothpaste, homeopathic products and diaper rash products would not require a review by Health Canada and the government would decide which ingredients products are not allowed to use. In addition, the government would not review claims made by these products, but would require them to provide disclaimers.
Moderate risk self-care products would include topical and oral pain relievers, cough and cold remedies and allergy relief medicines. The government would require some review and licensing based on evidence of safety and efficacy these products provided on monographs. Companies would be required to meet quality standards. A full review would not be required because of the standards Health Canada says are already in place, but the government notes that any claims made by these companies and products must be science-based.
Finally, higher risk self-care products would include those switching from prescription to non-prescription status, products containing new medicinal ingredients and those related to cardiovascular health. These products must undergo a full review by Health Canada and companies are required to provide evidence to support safety, quality and effectiveness of their products. Health Canada will have to approve all claims related to diagnosis, treatment, prevention, cure or mitigation of a disease or condition and again, claims must be based on science.
The government’s motivation behind this revamping of the RTOF is twofold. Despite Health Canada’s current regulations, not all self-care products require companies to provide scientific evidence to the government to support label claims. Also, the scrutiny between separate but similar products varies. Also, the government is concerned after public opinion research done in April of this year revealed that, of the Canadians surveyed, only 19 per cent considered themselves well informed when buying NHPs, only 29 per cent for cosmetics and just 37 per cent for non-prescription drugs.
Renelle Briand, media relations officer with the Public Health Agency of Canada, says that the goal of the new proposal is to create a more modernized approach to the regulation of self-care products while making sure consumers are properly protected and informed, but notes that there has been concern voiced by different groups of consumers and companies.
“It is not the Department’s intention to over-regulate the industry,” she says. “In fact, under the proposed approach, certain products, including many NHPs, will actually get to store shelves faster.”
Briand goes on to say that it is very important to her department to ensure a correct level of oversight for potential risks associated with different products is in place.
“Under the proposed changes, Health Canada would set requirements, including safety requirements, that companies would need to meet to sell these products,” she explains.
Currently, all NHPs can make claims, with Health Canada only reviewing those for non-prescription drugs. Claims made on cosmetics are not reviewed because the government does not consider them health claims.
The government’s plans to change the current regulations has the Canadian Health Food Association (CHFA) worried. The group claims that the new system could mean the disappearance of many supplements and an increase in the price of others. They’ve also criticized the public opinion research conducted by Health Canada, decrying the fact that only 2,500 Canadians were surveyed. Representatives from the CHFA declined to comment on the issue to the Neepawa Banner. Briand, when asked about the concern the CHFA has about the scope and time frame of the public opinion research the government did, said the government was not able to discuss the issue.
Sharing a local point of view, Karen Burton, who co-owns Neepawa’s Herbs for Health, a health food and supplement store, with Janet Husak, says she is definitely concerned about what Health Canada’s new regulations could mean for her business.
“It’ll affect us,” she affirms, noting she has mixed feelings about the issue. “I don’t think the [current] system is working. When they take something off the market, as in a vitamin or a mineral and it’s not allowed to be sold in Canada, it affects us. It affects everybody – there’s no way to get it unless you go down to the States or have it shipped from the States, but you can’t have it sold in Canada.”
Burton adds that the current regulations that are in place are, in her opinion, plenty on their own.
“Any more regulation will take the choice away from the consumer. If it’s a natural product, which consumers want available, then it’s going to affect the business and it’s going to affect the consumers,” she attests. “The demand [for NHPs] is getting stronger all the time. In the two years that we’ve been here, we’ve noticed a huge change...it’s amazing.”
