When Congress passed the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a unique marketing position. Unlike prescription drugs, which must be rigorously tested to prove both safety and efficacy before they are approved by the Food and Drug Administration (FDA) for commercial release, dietary supplements can go to market immediately. The FDA monitors the “claim” to ensure there is no implied cure wording and the Federal Trade Commission (FTC) assesses the truthfulness of the label claim only if there is a complaint.
Launching a natural health product in Canada can be a tricky process. As consultants to the industry for nearly 15 years, we have helped hundreds of companies quickly and successfully introduce their products to the Canadian market.
In the evolving world of nutrition, there’s always something new to take note of – novel ingredients, innovative dosage forms, fresh approaches to product packaging.
The clean label movement continues to gain momentum. As companies work to ensure their products are formulated as cleanly as possible--that is, to “remove the unpronounceable ingredients and focus on natural ones”--they frequently encounter obstacles along the way.
The regulations surrounding foods supplemented with bioactive ingredients (such as vitamins and minerals) have been evolving in Canada for quite some time. As Health Canada continues to work toward their long-term goal of regulating supplemented food products as foods rather than natural health products, manufacturers must ensure their product is compliant in the meantime.
Read on to learn what food and natural health product companies should know about the current supplemented food regulations in Canada.
Background on Temporary Marketing Authorization Letters (TMAL)
Earlier this year, Health Canada released a guidance document entitled, Category Specific Guidance for Temporary Marketing Authorization: Supplemented Foods. The purpose of this document is to outline the process for stakeholders to obtain a Temporary Marketing Authorization Letter, allowing them to temporarily sell their supplemented food product in Canada.
Prebiotics and probiotics aren't going anywhere. In fact, this emerging market has become so popular in recent years that there are now two major events dedicated solely to prebiotics/probiotics.
Our clinical team will be attending Probiota Global (Amsterdam, Feb 2-4, 2016) and Probiota Americas (Chicago, May 31-June 2, 2016) to share knowledge, explore new opportunities and network within this exciting area of health research.
As we gear up for next week's conference, we take a look at one of the most challenging aspects of the research and development (R&D) process for companies looking to bring prebiotics/probiotics to market.
Today's piece is a special guest post by William Rowe, President and CEO of Nutrasource, in response to the CBC's retraction of the Marketplace broadcast on supplements.
Last November, CBC's TV program Marketplace aired a special report on vitamins and other supplements. The broadcast reported that popular brands of protein powders and vitamin C were not living up to their label claims.
Study designs need to support the final claims including marketing claims. Risk management is a key aspect of formulating a robust clinical development program and may include proof of concept studies such as dose ranging or multiple dose studies and pilot studies, prior to engaging in pivotal clinical studies to determine evidence of effect and variability around changes resulting from supplementation with the investigational product.
There are many questions that must be asked, and consecutive steps planned, in order to successfully develop and launch a dietary supplement. These questions include: