July 2014

Source Nutraceutical, Inc. E-Newsletter

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.

supplements
A supplement is a supplement is a supplement or is it?
Are supplements regulated the same way in Canada as in the USA?
Can you sell the same supplement in Canada as in the USA?
Not sure of the answers? Source Nutraceutical, Inc. is!

The following is a primer on some of the similarities and differences in the way supplements are regulated in Canada and the United States.

 

Definitions:

For starters we don’t even call supplements the same thing – in Canada we use the term “natural health product” (NHP for short) to encompass products such as vitamins, minerals, amino acids, essential fatty acids, homeopathic medicines, traditional medicines, animal and plant extracts, and probiotics.

In the United States similar types of products are called “dietary supplements”.

Another important difference is that in Canada, NHPs are a subset of drugs whereas in the USA dietary supplements are a subset of foods.

 

Governing Statutes:

Natural Health Products are subject to the relevant provisions of the Food & Drugs Act and the Natural Health Products Regulations. Dietary Supplements are subject to the Dietary Supplement Health & Education Act (DSHEA), the federal Food, Drug & Cosmetic Act and relevant FDA regulations.

 

Labelling:

A dietary supplement is intended to supplement the diet and contains one or more “dietary ingredients” (e.g. vitamins, minerals, herbs, botanicals, enzymes). Similar to a food product with a Nutrition Facts panel the label of a dietary supplement must bear a “Supplement Facts” panel.

Natural health products do not carry Nutrition or Supplement Facts panels but rather declare the amounts of medicinal ingredients per dosage unit and list the non-medicinal ingredients present. NHPs must also carry specific directions for use as well as the duration of use, warnings, cautions and any contraindications and a natural product number (NPN or DIN-HM).

Functions / Claims:

Dietary supplements can help ensure that you get an adequate intake of essential nutrients and/or help reduce your risk of disease. As such, dietary supplement cannot make disease treatment or cure claims.

NHPs on the other hand, because they are defined as a subset of drugs must make a claim on their labels and it can range from a health maintenance to a disease treatment / prevention claim depending upon the quality and amount of scientific evidence available to support the claim(s).

 

Premarket Evaluation:

Suppliers of NHPs must demonstrate to Health Canada that their products are safe, effective and of suitable quality prior to entering the market place. Products accepted for sale by Health Canada are issued a license and an eight digit natural product number. The number, preceded by the letters ‘NPN’ or ‘DIN-HM’ (for homeopathic medicines) must be on the principal display panel of the product.

Product premarket notification is not a requirement in the United States; however, there is a requirement for notification of ‘New Dietary Ingredients’ (NDIs). Evidence supporting the safety of the ‘new dietary ingredient’ must be provided to the FDA at least 75 days before the ingredient is introduced into interstate commerce.

 

Good Manufacturing Practices (GMPs):

GMPs for natural health products are spelled out in law in the Natural Health Products Regulations. NHPs must be manufactured, packaged, labelled and /or imported by licensed establishments. Site Licenses are issued by Health Canada based upon a company / facility’s ability to implement and comply with Good Manufacturing Practices for NHPs.

The United States recently introduced GMPs for dietary supplements into law, with generally similar criteria to Canadian GMPs. However, sites are not required to be licensed in the United States.

Inspections of facilities for GMP compliance, though not routine, are more frequent in the United States than in Canada. Currently GMP compliance is largely a paperwork exercise and self-attestation process in Canada. The Canadian government is currently consulting stakeholders on a third party audit system.

Is a dietary supplement regulated the same as a natural health product?

No it’s not, but there are many similarities that will enhance your ability to market that same product north and south of the 49th parallel (e.g. GMPs, ingredient safety).

 

Is it possible to sell the same supplement in Canada as in the United States?

Yes, but there are some things you need to beware of:

  1. Not all ingredients are classified the same in Canada as in the USA. Some ingredients acceptable for over the counter sale in the United States are classified as e.g. controlled or prescription drugs in Canada.
  2. Products will need to obtain a license in Canada prior to going to market; however, if you have safety and efficacy data already for your product (e.g. safety data for NDIs) it will make the process much easier.
  3. Labels will need to be changed to meet the requirements of the Canadian or US markets.
  4. GMPs will need to be met for both Canada and the United States; however, facilities must also be licensed in Canada.

 

The preceding is a high level overview of the Canadian and American laws for supplements and does not cover all of the requirements. For more information on marketing your supplements in Canada and the USA contact Source Nutraceutical, Inc. today.

Our experts at Source Nutraceutical know the similarities and differences in the rules and regulations and can help you enter the Canadian and/or US markets quickly, efficiently and compliantly. Contact us today at regulatory@sourcenutra.com to find out how we can assist you.

Did You Know?

A significant portion of the world’s population is now over 55 years of age, most notably in North America, Western Europe and China. This segment of the population is one of the key drivers of the growth of the supplement and natural products markets due to their increasing interest in selfcare, healthy lifestyles and healthy aging. It is projected that by 2020 one out of every six Canadians will be over the age of 65 (~ 6.5 million people) and ~55 million Americans will be 65 years and older.

http://www.ats-sea.agr.gc.ca/inter/4367-eng.htm#f

http://www.aoa.gov/Aging_Statistics/Profile/2011/4.aspx

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 2014/2015 (info@sourcenutra.ca).

Source Nutraceutical, Inc. is your “one-stop-solution” for regulatory compliance, graphic design, mandatory bilingual (English & French translation) labeling 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.

Join Source Nutraceutical, Inc’s Linkedin Discussion Group

LinkedIn-Logo-2CAnd join the ongoing discussions on current issues.