Success for Supplements Lies in the Delivery

3/11/14

About 60,000 years ago, the dietary supplement industry was essentially a bunch of Paleolithic Hunter-Gatherers. After a few days away from the cave, they gathered around the fire and traded whatever edible, medicinal, and poisonous plants they might have picked up in their travels. From their weathered rabbit skin pouches they removed the dried, rock-like nuggets found oozing out of the trees where the goats rubbed their horns or the leafy greens found growing by the sandy shores of a small stream that made their breath smell less Paleolithic.

Their experiments in botany and pharmacognosy matured, slowly evolving into what became known as the Agricultural Revolution. They began to write about their findings and document uses for the many gifts nature had bestowed upon them. Back then, the choice delivery formats for botanicals were very simple: eating the plants, maybe a crude version of a compress—or possibly a tea.

At some point, someone dropped something in the fire, odorous smoke billowed out and the rest is history. Today, “delivery methods” of supplements is a quickly growing area within the dietary supplement industry alongside branded novel ingredients.

The passage of time has not simplified things.

According to DSHEA, dietary supplements are supposed to deliver their actives to the bloodstream via the GI tract. Boundary stretching is a common challenge for regulators. Lozenges’ typically deliver actives through the mucous membrane of the mouth and mouth sprays have been accused as being inhalants. Next comes the transdermal patches and microencapsulated-controlled release products.

It is apparent that the strong entrepreneurial hand of big-pharma and biotech has reached around into the dietary supplement industry and has offered up many of its tricks. Contract manufacturers needing to find that competitive advantage are now differentiating themselves by variety of delivery methods.

Branded novel ingredients now incorporate these new delivery methods by giving us innovative amalgamations of molecules as old as caffeine from green tea combined with chemicals from berries to create a highly absorbable new version of caffeine. This celebration of pharmacognosy is said to allow for significantly less caffeine use without decreased effect.  What an innovation…

Taking something good and making it better is an example of innovation. When selling green tea products for its caffeine content isn’t enough, one step is to look into alternative or novel delivery methods. This, I believe is the moment when natural products mature into nutraceuticals.

I know not what out forefathers would have thought about such a transition. I suspect they’d be amazed at the progress and concerned about efficacy and safety. What I do know is that delivery methods, just like novel branded ingredients and the complicated blends containing them, are frequently a struggle for any analytical lab. Testing the caffeine in green tea is old news. Testing the caffeine in a product that is an amalgamation of phytochemicals is new and methods are not always available. This is precisely why having a good working relationship and clear transparent communication between the innovator, the manufacturer, and tester is the formula for success.

Categories: Analytical Testing, Product Verification/Validation, Regulations