Rare is the company that solely sows the seed, grows the botanical, processes or combines it with other ingredients and finally puts the finished product on the store shelf. A handful of them still exist today, making up many of the leaders in this industry. These atypical "soil to shelf' companies have the opportunity to be a greater part of a product’s quality at each precious step in the manufacturing process. They have the ability to identify and botanically key an ingredient from its flower parts while still growing in the field. While this is the most ancient of all the techniques, it is still widely accepted by regulators worldwide. This luxury only comes to those who grow their ingredients. For mostly everyone else, material is bought and sold in forms requiring more advanced testing techniques. This means an internal lab must be built to meet the requirements of cGMPs (current good manufacturing practices) or an external lab must be selected as a partner.
More likely, companies process only a part or possibly a few parts of a product’s journey from soil to shelf. It is not uncommon for a dietary supplement to pass through four or more companies along its production. Each might have a different justification for select compliance with the cGMPs. Even in this highly regulated industry, it is a combination of interpretation of the law and an anemic, but growing FDA staff to enforce the law that dictates the quality of this industry.
While the entrance fee into building an internal lab may at first seem high, considering the variety and cost of equipment found in your average contract manufacturer, including encapsulating machines, mixers, grinders and so on, its relatively low. Internal labs may also appear to be a safe option and offer more oversight than an external lab as well as a reduction in turnaround time of test results. On the contrary, internal labs also offer numerous liabilities such as:
- Staffing issues - can bring a smooth operating company to its knees when one liquid chromatography chemist quits or gets sick;
- Technical acumen of staff - constantly being challenged as the industry evolves;
- Equipment maintenance - the more expensive the equipment, the more expensive it is to keep it running;
- Possible collusion between staff - it is possible for Jack in testing to be friends with Jill in purchasing giving reason for less than ethical choices to be made); and,
- Capacity - to keep up with the volume of analysis, a decision must be made to run an internal lab within your core business or potentially operate out of compliance due to staff shortages or capacity to keep up with that darn conveyer belt that never stops moving.
The growth of this industry is continuously increasing the complexity of materials needing to be tested; it’s nearly impossible to keep up while trying to be the best at something else. Lastly, internal labs are a small part of a big business while external labs are a separate, unbiased business that thrives on other business for its livelihood. For this reason, effectively choosing an analytical lab partner is critical.
Choosing a contract analytical lab (or even better, several contract analytical labs) can be daunting task, as some test everything from active pharmaceuticals ingredients and industrial adhesives to vitamins and herbs. Can they be good at everything? Some labs offer most of the tests a supplement company needs and also sell products in the same industry. Is there a potential conflict? Others specialize in specifics types of tests and cannot service routine testing needs such as heavy metals, pesticides and microbiology. Can a niche lab really support your needs? Some labs will gladly take on any business, subcontract it out without informing the company and then modify the final reports to make it their own. How can they be accountable? Then, unfortunately, there are the cheaters. They are definitely out there. They have been caught but simply continue their ways preying on the ignorant, unsuspecting and customer concerned only with turnaround time and cost rather the most important thing which is quality.
Fortunately the American Herbal Products Association (AHPA) can help. Among their nearly infinite resources available to the industry, AHPA recently created a subcommittee within its analytical labs committee. The subcommittee designs and develops a data base of analytical labs that AHPA has approved. Thisapproval process is still in the works and includes many critical parameters that must be considered when choosing an analytical lab partner. With this resource, the work will be half done for a company so it can simply look at a small list and then make its introductory calls to schedule an audit.
Also several articles on the topic of analytical labs can help brand owners choose a partner. The most relevant is one published by Natural Products INSIDER, "Choosing an Analytical Lab" where AHPA's former vice president of scientific and technical affairs, Steven Dentali, Ph.D., offered simple guidelines for choosing a contract laboratory partner.
The article is only two pages long, but goes into great detail about critical considerations when choosing an analytical lab. It includes this very simple check list of what to ask your lab.
Choosing a partner analytical lab is a process that cannot be performed quickly or in a vacuum, and never will one lab be able to satisfy all your compliance needs. Labs should be an extension of your quality control team and relying on one alone is never advisable. Find three that together complement each other's strengths. Go to lab X for your botanical identity and assay testing, lab Y for your metals, pesticides and microbiology, and lab Z for special more detailed or complex testing require lower limits of detection. This newly formed team of labs will be sure you stay compliant, effective and relevant in the industry.
Élan M. Sudberg is CEO of Alkemist Labs (alkemist.com), an analytical testing lab. He holds a degree in chemistry from California State University, Long Beach, and has authored numerous journal articles on phytochemistry and analytical techniques for the natural products and nutraceutical industry. He is a newly appointed board member of AHPA’s Education and Research on Botanicals Foundation and is the chair of the Hemp and Medical Marijuana committee.