February 2015

consumer health products: changes and opportunities

Welcome to our E-Newsletter, your “one-stop” for the information you need to ensure success in the Canadian market. Learn about current issues and how they may affect your business, what’s new at Source Nutraceutical, Inc., how we can help you and where you can find us.

Our February newsletter continues on from our last newsletter with the theme of
change and opportunity.

EnewsImage3NHP CLASSIFICATION SYSTEM

CHANGES

Effective September 1, 2014, all new natural health products sold in Canada are expected to be in full compliance with all regulatory requirements prior to entering the marketplace. Thus all products, at all levels of distribution, should now comply with all licensing, labelling and compositional requirements as per the Natural Health Products Regulations. In order to bring new products to market as efficiently as possible the Natural Health Products Directorate (NHPD) has identified three classes of products. If your product meets the criteria for Class I or Class II products you can theoretically get your license in 10 or 30 days respectively. However, your product will most likely look like many other products on the shelf as you will be providing pre-cleared information, such as established monographs, to confirm the safety and efficacy of your products. A license for a Class III product will take 180 (+10) days plus ‘new’ safety and evidence information.

OPPORTUNITIES

Differentiate your products from all the rest. Clinical trials to support safety and/ or efficacy can be done relatively quickly and inexpensively. Source Nutraceutical’s Clinical Studies team will work with you to identify the key differentiators of your product and develop a cost effective and targeted clinical studies program that will provide Health Canada with the necessary evidence to support your unique formulation and /or health claims. Be a step ahead of the competition- contact our Clinical Studies Team today to find out how we can help your company and products stand out on the retail shelf. (regulatory@sourcenutra.ca)

EnewsImage2VANESSA’S LAW

CHANGES

Bill C-17, Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) received Royal Assent on November 6, 2014. This enactment amends the Food & Drugs Act regarding therapeutic products by giving Health Canada the ability to

  • Recall unsafe therapeutic products
  • Impose tougher fines and penalties
  • Direct label change/modification, and
  • Seek an injunction.

These changes came into effect immediately upon Royal Assent. Other changes to further enhance patient safety require the development of supporting regulations and will provide the opportunity for stakeholder consultation.

The Act applies to therapeutic products including prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices (but not to natural health products).

OPPORTUNITIES

Now is the time to review the text of Vanessa’s Law, become familiar with its requirements and identify any gaps in your existing quality control/ assurance programs. As supporting regulations are drafted become actively involved in the discussions and consultations.

Don’t wait for the government to come knocking on your door- be proactive and ensure the ongoing safety and quality of your products. Contact Source Nutraceutical today for more information on how Vanessa’s Law might affect your company, products and operating procedures. (regulatory@sourcenutra.ca)

EnewsImage1NEW REGULATIONS FOR OTC DRUGS

CHANGES

Natural Health Products, Non Prescription Drugs, Cosmetics, Disinfectants- is the level of regulation consistent with the level of risk? That is what Health Canada is looking at under their proposed new Consumer Health Products Framework. This new framework “seeks to establish a consistent and aligned approach to the regulation of health products intended for consumer use”. For example, non-prescription drugs, a lower risk category, are currently regulated in the same manner as their higher risk counterparts- prescription drugs. Similar products, e.g. cosmetics, can be categorized under different regulatory frameworks simply on the basis of an ingredient and/or health claim.

OPPORTUNITIES

The main focus of the consultation, open for stakeholder input until February 27, 2015, is the creation of new risk-based regulations for non-prescription drugs. Changes have been long in coming so don’t delay- comment on the regulatory proposals before February 27. You will have to comply with these new regulations once they are promulgated so make your voice heard.

DID YOU KNOW?

Saccharin, a permitted and then banned food additive / sweetener in Canada is once again permitted. Delisted in the 1970s based on human health concerns, saccharin has now been confirmed safe for human consumption and is permitted for use in such foods as breath freshener products, chewing gum, unstandardized canned fruit, and unstandardized frozen desserts among others. This position is consistent with those of both the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the Food and Agriculture Organization of the United Nations and the World Health Organization and the European Commission’s Scientific Committee on Foods.

Health Canada is further proposing that saccharin be allowed for use in table top sweeteners.

CONTACT US

Source Nutraceutical knows the ins and outs of the Canadian regulations for all consumer products. Contact us today (regulatory@sourcenutra.ca) and let us help you make the regulations work
for your products.

Whatever your regulatory, packaging and/or fulfillment needs are- contact Source Nutraceutical today to learn how we can help you achieve brand success and market penetration in 2015 (info@sourcenutra.ca).

Source Nutraceutical, Inc. is your “one-stop-solution” for strategic consulting, regulatory compliance, clinical trials, graphic design, bilingual labelling and importation and fulfillment services for foods, natural health products, cosmetics, medical devices and pharmaceutical products in Canada. Contact us today to learn more about how we can help you get your products to market quickly, compliantly and cost effectively.

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