Avoiding Test Anxiety

An important, obvious aspect in manufactures not being conned via economic adulteration is testing. What isn't so obvious: Determining what bloody tests to run.

"There is a need for more testing methodologies, and more ingredient information databases, but there is no one size that fits all," says Dr. Michael Lelah, Ph.D., the technical director at supplement manufacturer NOW Foods in Bloomingdale, IL. "The huge variation in natural ingredients and products means that companies need to pick and choose what works for them, or develop or adapt their own methodologies."

So, what does NOW Foods do?

Or, to be more exact, what doesn't it do? "We have seven laboratories with different instrumentation run by trained professionals to test our ingredients and products to ensure they contain what they should, and that they are not contaminated or adulterated," Lelah says. "We have methodologies for testing potencies of vitamins, minerals amino acids, botanicals, and other nutritionals. We have methodologies for ensuring correct identity of our ingredients. We have methodologies for testing for heavy metals, pathogens, and other contaminants. We have methodologies for testing for adulteration and spiking by pharmaceuticals. We have methodologies for testing to see if ingredients have been irradiated. We have methodologies to ensure that tablets, capsules, and softgels are manufactured correctly."

The good news for less experienced companies is that guidance abounds. In the latest revisions to its Food Chemicals Codex, the United States Pharmacopeia (USP) recommends testing for carbon isotope C14 in determining whether an ingredient is synthetic or natural. Dr. Markus Lipp, Ph.D., director, food standards at USP, says that all living things contain a certain amount of this isotope.

Some ingredients have well-established marker compounds and measurement methods, says Dr. Duffy MacKay, N.D., vice president, scientific and regulatory affairs, at the Council for Responsible Nutrition.

"In addition, there are validated test materials available with fixed amounts of marker compounds to test against to ensure that your lab is doing it correctly, that is a standardized sample to test against (NIST, AHP, USP)," he adds. "In these cases, it is recommended to use these established guidelines for what to measure and how." 

But what if methods and test materials aren't available?

"Manufacturers are still required to establish a protocol to measure identity, purity, strength, and composition," MacKay says. "So a manufacturer is responsible to set specifications for these measurements and develop its own methodology to test for them. Upon GMP inspection, a manufacturer must scientifically justify these methods."

It's costly to do this, of course, but it's an essential investment. It's expensive, damaging, and embarrassing when integrity and reliability are compromised. If that doesn't concern manufacturers, perhaps they're in the wrong business.