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October 25, 2019
The 25th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA) raises many questions about the pros and cons of the U.S. law, the need for changes and the need for improvements.
It’s also a time to reflect on whether any future amendments to DSHEA should incorporate aspects of regulatory models from other parts of the world. During a May 16 public meeting held by FDA to discuss “Responsible Innovation in Dietary Supplements,” participants brought up comparisons to Health Canada’s equivalent supplement product regulations, followed by more emphasis at the end of the day when Health Canada’s Director General of Natural and Non-prescription Health Products made a presentation.
Comparisons between the Canadian and U.S. models raise many questions. For example, what are the benefits of the Canadian regulatory approach, and should portions of it be adopted in the U.S.?
Before exploring those questions, it’s important to understand differences in how supplements are treated in the two countries. In the U.S., dietary supplements are regulated as a category of foods, but in Canada, dietary supplements—or what Health Canada calls “Natural Health Products” (NHPs)—are treated as non-prescription drugs.
According to Health Canada, under the NHP Regulations, which took effect Jan. 1, 2004, NHPs are defined as:
Vitamins and minerals
Traditional medicines such as traditional Chinese medicines (TCMs)
Other products like amino acids and essential fatty acids (EFAs)
NHPs must be safe to use as over-the-counter (OTC) products and do not need a prescription to be sold. A variety of topical and ingestible dosage forms are included.
Since 2004, nearly 55,000 licenses for NHPs have been issued, representing 81,629 products, according to Health Canada.
In getting products licensed and new ingredients and claims approved, I have had positive experiences working with Health Canada. My experience began in the 1980s with innovative sports nutrition and weight loss products that Health Canada received with open arms and licensed within months.
In the U.S. during that time, FDA mostly opposed these types of products, novel ingredients and marketing claims through combative and oppressive actions. However, after many years of time and money spent by industry members and the public, DSHEA was passed into law. It marked a major step in the right direction, albeit with room for improvement.
In general, having worked with both systems, Health Canada’s approach has some advantages that benefit both supplement takers and supplement makers. The Canadian model allows brand holders to provide the public with effective, quality and safe products, while eliminating controversy and boosting consumer use and confidence due to the product approval process.
Examples of some of these advantages include:
More up-to-date and detailed definitions, including naming specialty ingredients like probiotics.
Maintenance of an ingredient database with ingredient legal status.
Official comprehensive ingredient monographs are published with ingredient types, dosages, claims and other details.
Medicinal ingredients have specific safe and effective dosage ranges, use instructions, and compositional specifications for consistency.
Products are approved and licensed.
A database of all licensed products is maintained.
Site licenses are issued for companies involved with manufacturing, packaging, labeling or importing natural health products for sale in Canada.
Detailed requirements related to quality standards and testing are developed and published.
Synthetic duplicates of essential nutrients, plus other substances of botanical and animal origin, are permitted as medicinal ingredients.
Health Canada is willing to cooperate with supplement companies to advance product ingredients and claims (also referred to as uses or purposes).
Under a best-case scenario, FDA would adopt the entire Canadian NHP approach, establishing it under a new product category. This is not a far-fetched idea when you consider FDA established a new product category for regulating tobacco products. By comparison, NHPs are already proven to benefit public health and have a history of use.
The U.S. should consider adopting the following portions of the Canadian NHP approach to benefit supplement takers and makers.
Definition of dietary supplements – Provide more details about specific dietary ingredients, nutrients and beneficial substances, like probiotics, bioflavonoids and enzymes; and add synthetic duplicates of substances of botanical, animal, fungal and other natural origin, for use in dietary supplements as dietary ingredients.
Site licensing – license businesses involved in manufacturing, holding, other processing and distribution. In addition to FDA or state inspection approvals, one approach to support and expedite the licensing process can be for FDA to accept the cGMP (current good manufacturing practice) certifications of organizations currently being used, such as from the U.S. Pharmacopeial Convention (USP), Natural Products Association (NPA) and NSF International.
Product licensing – License dietary supplement products to eliminate the controversy perpetuated by the media, and create product formula standards for safe and effective dietary ingredients, composition, dosages, claims and uses/purposes.
Legal dietary ingredient database – FDA can create such a database by working with the dietary supplement industry and the National Institutes of Health’s (NIH’s) Office of Dietary Supplements’ (ODS) existing product label database.
Approved ingredient monographs – Developing approved ingredient monographs could be jumpstarted using Health Canada’s approved ingredient monographs that would apply to dietary supplement products in the U.S.
In closing, as the dietary supplement industry considers improvements to U.S. law, it should consider incorporating aspects of Health Canada’s regulatory model. On the 25th anniversary year of DSHEA, we have an opportunity to foster an evolution of the law that will benefit consumers and industry for decades to come.
Daniel Gastelu, MS, MFS, is founder and president of Health Product Business Success LLC and SUPPLEMENTFACTS International LLC; a dietary supplement expert; and director/professor of the International Sports Sciences Association and College of Exercise Science (emeritus). He can be contacted at: [email protected] or (973)729-2240.
Founder and president, Health Products Business Success LLC
Daniel Gastelu, MS, MFS, is founder and president of Health Products Business Success LLC and SUPPLEMENTFACTS International LLC; a dietary supplement expert; and director/professor of the International Sports Sciences Association and College of Exercise Science (emeritus). He can be contacted at: [email protected] or (973)729-2240.
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