Although we create our own unique herbal formulas, we don’t manufacture and bottle the products ourselves. Instead, we contract out the actual manufacturing to a few carefully chosen, very specialized contract manufacturing companies here in the western United States. We currently use 4 or 5 contract manufacturers in California, Utah and Arizona as suppliers for different products and packages. Why so many?
Manufacturing herbal and homeopathic products is a highly specialized, highly regulated, and machinery-intensive process. Procuring and testing raw ingredients, weighing them, blending them together, putting the blended powder into capsules, and packaging them, all requires a great deal of specialized machinery, but more than that, those machines require temperature and humidity control, positive air pressure and filtration to control dust particles, and special manufacturing buildings to house the air-handling equipment and the machinery. Both the buildings and the machines must be easily and completely cleaned between each product’s production run. Particular formulas may require additional equipment, like high-shear particle granulators, flash dryers, liquid heaters and stirrers, or capsule/tablet spray coating equipment.
Keeping all these machines running requires a lot of scheduled maintenance. It also requires unscheduled maintenance, because machines break. Fixing them quickly requires an on-site machine shop capable of fabricating repair parts to precise tolerances in food-grade and pharmaceutical-grade stainless steel. And because the equipment is so expensive to buy and maintain, you really need to be running at least two eight-hour production shifts a day to make the investment pay off. Since each encapsulation machine can typically produce between 100,000 and 300,000 capsules per hour, this translates to between 1 and 5 million capsules per day.
Liquids and creams (Like ClearLungs Liquid and Chest Rub) usually need to be manufactured in an environment that is completely separate from dry powder facilities (like capsules and tablets) to prevent dust contamination of liquids or spills that contaminate powders. Contract manufacturers typically do liquids or powders, but not both. Those few companies that manufacture both liquids and powders typically house them in completely separate buildings.
And then there are the regulations. Sometimes you may hear from uninformed journalists that supplements are unregulated, but don’t you believe it. Every aspect of supplement manufacturing is regulated through Good Manufacturing Procedures, or GMPs. Some industry comedians claim that GMP stands for “Get More Paper”, and they aren’t far off. Master manufacturing records, individual batch records, written procedures for everything from how to wash your hands or scrub a toilet, to how long to blend powders to make sure they are uniform. Detailed testing is required for each individual input ingredient, and then more testing is required again for the final manufactured product.
As if that wasn’t enough, homeopathics are classified by the FDA as over-the-counter (OTC) drugs or pharmaceuticals, which require even stricter regulations, and a completely different set of GMPs. For example, while supplement labels (like food labels) must list ingredients in descending order by weight, drug ingredients must be separated into “active ingredients” like homeopathics, and “inactive ingredients” (anything else), and each category must be listed alphabetically on the label. Less than one in 10 contract manufacturers of supplements is also qualified to manufacture OTC drugs, and most wouldn’t even want to.
For all of these many reasons, the actual manufacturing of any natural product is best left to the experts at contract manufacturing firms, at least until a company reaches a size sufficient to warrant its own custom production facility. Most natural products companies don’t reach that point until they become very large (often publicly-traded) companies. Finding the very best contract manufacturers isn’t easy, but our need for OTC manufacturing weeds out a lot of lesser candidates, and our careful review and on-site qualification process ensures that we always have trusted, capable and reliable manufacturing partners.
But our work doesn’t end there. We also inspect every finished batch of product ourselves, to verify that ongoing production regularly meets or exceeds our requirements and standards. And we work closely with each manufacturer to ensure that our products are continuously improved over time as processes and standards evolve. Making great products is never easy, but good partners make it possible.