Do you manufacture, import or market Natural Health Products (NHPs) that would come under the umbrella of “Performance Supplements”? These would include workout supplements, muscle enhancers, or energy products. If so, you need to be aware that Health Canada, as per one of their latest Compliance Monitoring Projects, will be actively sampling and testing such products to ensure compliance with the product’s market authorization.
What sort of tests will they be doing? Specifics have not been disclosed, and testing can vary from product to product, but the broad test categories would include ingredient verification, contamination, and undeclared ingredients. Ingredient verification involves simply testing a product to ensure the correct medicinal ingredients are in the bottle and in the correct amounts. Contamination testing is looking for the presence and levels of things like heavy metals, pesticide residues, or pathogens.
However, what is of particular concern to Health Canada, and one reason why they are singling out Performance Supplements versus other NHPs, is the last category: Undeclared Ingredients. Performance Supplements have garnered a bit of notoriety over the years with respect to undeclared ingredients, which are usually banned substances or prescription drugs. How, you may ask, would such ingredients end up in my product? In almost all cases it boils down to two factors: dishonesty and carelessness.
“Performance Supplements have garnered a bit of notoriety over the years with respect to undeclared ingredients, which are usually banned substances or prescription drugs. How, you may ask, would such ingredients end up in my product? In almost all cases it boils down to two factors: dishonesty and carelessness. “
Dishonesty and carelessness
The dishonesty can occur anywhere in the supply chain – a raw material manufacturer, a raw material supplier, a finished product manufacturer, a bulk supplier, a bulk or finished product packager/labeler, a distributor, or a retailer – and can involve one or more employees at any of these sites. The motive, as always, is financial. If a product outperforms all of its competitors due to the presence of the illegal substance, guess which product the unsuspecting public will buy.
The carelessness, on the part of the otherwise honest parties who are involved, occurs anywhere downstream of the dishonest deed. Carelessness results from not having effective Good Manufacturing Practices (GMP) and related quality controls in place. Such practices would include proper vetting and qualifying of suppliers, implementing proper raw material and finished product specifications, testing all raw and finished goods to specifications, having access to and reviewing production records, having qualified QA and manufacturing personnel on staff, and careful tracking of inventory.
While we don’t know what undeclared ingredients are going to be targeted when Health Canada pulls samples from shelves, we can make some educated guesses. Excellent resources are Health Canada’s online Recalls and Safety Alerts database (Canada) and the FDA’s Warning Letters database (US). The information in these databases highlights the sorts of banned substances that have been popping up in products and, therefore, what is on the regulatory bodies’ radar.
But, of course, once your tainted product is on the market there is little recourse other than to recall and face the consequences. The old adage “you cannot test quality into a product,” still rings true. Testing alone for banned substances is difficult unless you know exactly what you are looking for. Also, sometimes the perpetrators of banned substances will come up with creative ways to fool the test; for example, adding the substance in such tiny concentrations in hopes of avoiding detection, but then hike the dosage (serving size) in order to still achieve the effect.
This brings us back to our fundamental truth: Quality must be built into a product, starting from the initial sourcing of materials right to the end of the finished product shelf life. You can achieve through the development, implementation, and execution of an effective and rigorous GMP based quality program. This is true of all health products, performance supplements or otherwise.
Are you concerned about enforcement, or do you have a proactive desire to ensure the quality and compliance of your products?
If so, feel free to contact dicentra and we will discuss how we may be of assistance.
Dietary Supplement Ingredient Advisory List:
https://www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list
Recalls and safety alerts:
https://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php
Warning Letters:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters