A Supplement is a Supplement, or is it?

Interested in selling supplements into the Canadian and/or U.S. market, but don’t know where to start? Supplements regulation in Canada and the United States have similarities, but the differences are significant.

For starters the countries don’t even call supplements the same thing—in Canada they use the term “natural health product" (NHP) to encompass products such as vitamins, minerals, amino acids, essential fatty acids (EFAs), homeopathic medicines, traditional medicines, animal and plant extracts and probiotics. NHPs can come in a variety of dosage forms, such as tablets, capsules, liquids, sprays and creams, but all are designed for over-the-counter (OTC) uses and self-limiting conditions. There are no prescription NHPs, but they are regulated as a subset of drugs and, by definition, are required to carry a health claim.

In the United States, similar types of products are called “dietary supplements." Dietary supplements are regulated as a category of foods, and as the name implies, their use is intended to supplement the diet. Dietary supplements are to be consumed orally and thus, dosage forms are limited to ingestible forms.

Beware: Some substances classified as supplements in the United States (e.g., DHEA) are regulated as controlled or prescription drugs in Canada.

Governing Statutes

NHPs are subject to the relevant provisions of the Food & Drugs Act and the Natural Health Products Regulations. The regulations are implemented and overseen by the Natural Health Products Directorate (NHPD) of Health Canada and enforced by the Health Products & Food Branch Inspectorate also of Health Canada. The Marketed Health Products Directorate is responsible for post market surveillance of health products.

Advertisements are pre-cleared by independent third-party agencies with Health Canada only getting involved when blatant violations of the law and/or health and safety issues are brought to its attention.

In the United States, dietary Supplements are subject to the Dietary Supplement Health & Education Act of 1994 (DSHEA), the Federal Food, Drug & Cosmetic Act, the Fair Packaging & Labeling Act and other relevant FDA regulations. FDA has primary responsibility for the safety and labelling of dietary supplements, whereas FTC has primary responsibility for the regulation of claims in advertising, infomercials, catalogues, websites, direct marketing materials, etc.

Burden of Proof

In the United States, the burden of proof lies with FDA to prove a dietary supplement is “unsafe" in order to prevent it from entering the market or to remove it from the market. In Canada, the burden of proof lies with the supplier to prove that product is safe and efficacious in order to go to and/or remain on the market.

Market Authorization

Suppliers of NHPs must demonstrate to Health Canada that their products are safe, effective and of suitable quality prior to entering the marketplace. Products deemed acceptable 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).  An NDI is defined under DSHEA to mean a dietary supplement ingredient that was not marketed in the United States prior to Oct. 15, 1994. Evidence supporting the safety of the NDI must be provided to FDA at least 75 days before the ingredient is introduced into interstate commerce.

Labeling

A dietary supplement is intended to supplement the diet and contains one or more dietary ingredients (e.g., vitamins, minerals, herbs, botanicals, enzymes, etc.). Similar to a food product with a Nutrition Facts panel, the label of a dietary supplement must bear a Supplement Facts panel. The label must also include directions for use, allergen labeling and where to report a serious adverse event.

NHPs do not carry Nutrition or Supplement Facts panels, but must declare the amounts of medicinal ingredients per dosage unit (and their source material) and list the non-medicinal ingredients present.  NHPs must also carry specific directions for use including the target population, the indication(s), the duration of use, the route of administration, risk information (such as warnings, cautions and contraindications) and a natural product number (NPN or DIN-HM). Mandatory information is required to be in both French and English.

Health Claims

NHPs, because they are defined as a subset of drugs, must make a health 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). Health claims are evaluated by Health Canada as part of the premarket notification process. Acceptable claims are identified in the product license once it is issued.

Dietary supplements, on the other hand, are forbidden under DSHEA to make claims for the treatment, prevention or cure of a specific disease or condition. Such claims would bring a dietary supplement under the category of an unauthorized drug. Structure/function claims, nutrient-content claims and some health claims (disease risk reduction) are permitted. Suppliers are responsible for ensuring the accuracy and truthfulness of claims they make and must be able to provide supporting evidence if challenged. They must also notify FDA within 30 days after marketing a dietary supplement bearing a structure function claim. Dietary supplements must also bear the following statement on their label: “This claim has not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease".

GMPs

GMPs (good manufacturing practices) for NHPs 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 GMPs for NHPs. Attesting that a product is manufactured under GMPs is also a requirement for a product license.

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

Compliance and Enforcement

As of September 1, 2014, all NHPs in commerce in Canada must be licensed with Health Canada. GMP compliance and site licensing have been enforced since 2006.

Since the introduction into law of GMPs in the United States, facility inspections are increasing as are the number of identified GMP deficiencies. FDA appears to be ramping up its enforcement actions for noncompliant facilities as is FTC with noncompliant product promotions.

Is a dietary supplement regulated the same as a NHP? No, but there are enough similarities that compliance in one regulatory jurisdiction will greatly enhance a brand’s ability to market that product north/south of the 49^th parallel.

For more on laws regulating the dietary supplement and functional food industry, check out INSIDER’s Regulatory Content Library.

Anne Wilkie ([email protected]) is senior government relations & regulatory strategy specialist at Source Nutraceutical Inc. (sourcenutra.ca).