Create Claims with Confidence

Labeling laws and truthful claims are critical for protecting the consumer, and they ensure a level playing field for participants. Even during times of stalled regulatory clarity and enforcement, the “golden rule" still applies: do unto others by ensuring product labels are truthful and not misleading.

As we know in this era of “alternative facts," it’s easy to make a claim, but harder to verify it with facts and science (Go science!). But science has a problem. Even when fully developed, it rarely provides the full 100 percent confidence that may be required to change beliefs and opinions (Boo, science!).

First example: identity claims. Many are aware that the identity of dietary ingredients needs to be stated on the product label. What is often missed is that verification through analytical tests to confirm identity are required on every batch of dietary ingredients—a minimum requirement under GMPs (good manufacturing practices).

Unfortunately, many identity methods miss the mark for validity and fitness for purpose—also a minimum requirement under GMPs that tends to be overlooked. But if an ID method does not detect the presence or absence of common adulterants for a material, then how is it meeting the minimum requirement? How is it considered suitable for its purpose? In most cases, more work is needed: an adulterants review, developing and adopting multiple methods that determine a material’s identity, and adequate supplier qualification are all keys to providing a more reliable assurance of identity. The “totality" approach to ensuring identity is especially helpful when nonspecific or indirect measures are used, like those based on infrared spectroscopy or thin layer chromatography.

Health claims also require scientific evidence (Go science!). Here the standards are clearer, but still not without confusion. The U.S. scientific establishment jury has decided that animal data, anecdotes and traditional use are not scientific, and therefore are not sufficient evidence to support a health claim. Past that, there are some gaps in minimum requirements. Ask 10 experts to get 10 opinions (One or two studies? Published or not?). But most agree that well-designed human studies, with differences in treatment versus control groups at more than a 95 percent confidence limit (known as P<0.05) are the path to health claims substantiation. This arbitrary cutoff can be criticized, too, because when P=0.051 (a confidence of 94.9 percent), a product is deemed no more effective than a placebo. The difference is the line between effective supplement and worthless snake oil. This confuses even most scientists, but it does set a pass/fail that can be evenly applied.

Science is increasingly useful in the verification of content claims. Now that analytical tools can quantify picomolar concentrations, almost down to the molecule, content claims can be powerful and truthful if investments are made in developing and verifying them. And since content claims are increasingly policed by consumer groups and class action attorneys, a failure to verify content claims can be painful.

In one recent example, the kombucha tea industry has been hit hard by a series of settlements involving mislabeling of alcohol, sugar and antioxidant content, and exploding bottles. Debate over which test methods were suitable for ethanol (one of the most frequently analyzed substances) led to an industry-wide effort to validate a method specific for kombucha. The validation in kombucha compositions was the last step required to rule out the slim possibility that kombucha contained unique matrix interferences that could make it difficult to measure with reliability. As a participant in the project, validation results from our partner laboratories showed a gas chromatography—flame ionization detector (GC-FID) method commonly used for ethanol in foods and beverages was fit for our purpose. After approval by the AOAC scientific expert review panel, the method is now being adopted by the kombucha industry as a standard method.

While not all methods require this kind of validation, the process is key. First brands need to verify the test method. Second, they verify the product against the claim they want to use with the verified test method. Then third, brands can put the claim on labels. In that order.

Here’s another catch about claims: evidence is only so good as it verifies the claim. Picture an ingredient made on the same manufacturing line as a common allergen. Is a test report and supplier checklist from last year sufficient to prove that a new shipment is allergen-free? Maybe, maybe not. The best test method in the world will not make up not knowing if the results from the last shipment can reasonably be predicted for the current materials. Verification is not just about testing.

Hopefully we can agree that there should be rules to verifying identification, and the same rules should apply to everyone. We should agree that claims should be based on science and facts, not beliefs and opinions. Go, science!

Blake Ebersole has led a number of botanical quality initiatives and formed collaborations with dozens of universities and research centers. As president of NaturPro Scientific (naturproscientific.com), Ebersole established quality compliance and product development services for supplements and ingredients such as ID Verified™. Follow him on Twitter at @NaturalBlake.