When greater testing sensitivity can cloud the issue of what's 'safe'

The issue has been percolating for some years, ever since the Prop 65 limits were put into place in California. This initiative calls for health warnings to be placed on products when certain contaminants reached specified levels. The levels for these contaminants, such as lead, were set by Prop 65 at much lower levels that what is called for in federal regulations. Over the years, the initiative has proven to be a gold mine for plaintiff’s lawyers, and budgeting to pay potential Prop 65 settlements has become part of doing business in California.

Sounding an alarm about heavy metals

Within the dietary supplement industry, the issue gained additional immediacy with the recent release of a report on protein powders conducted by a nonprofit group called The Clean Label Project​​. The report said in third party testing that many protein powders were found to contain detectable levels of toxins such as heavy metals like lead and cadmium. The report sounded alarm bells about other contaminants as well, such as BPA, a chemical that can leach into products along the way from plastic packaging. 

The report received significant pushback​​ from analytical testing experts within the industry. The report was released without peer review, which was one source of concern. (The organization’s director, Jaclyn Bowen, claimed that peer review of the report is planned, but said that the issue is a pressing public health concern and therefore quick publication was called for.) Stakeholders were also concerned both by a lack of transparency in how the tests were conducted and by what they saw as the bombastic way in which the results were framed.

“If you are going to insinuate that something is a public health hazard without a peer review—that’s just Instagram science,”​ said Dan Fabricant, PhD, CEO and executive director of the Natural Products Association​​.

Natural suite of chemicals

Experts contacted by NutraIngredients-USA said materials extracted from natural sources will usually contain at least some traces of other things, like lead or arsenic, that were present in the area where the feedstock for the material grew—whether it's a plant-based protein powder, a botanical extract, or what have you. Getting rid of every trace of heavy metals, to use one example, is impractical, which is why certain allowable levels were enshrined in federal law.

To achieve absolute purity, chemical synthesis is called for, and indeed this purity message is one of the things that the purveyors of synthetic analogues of natural compounds trade upon. Synthesized ingredients have their own regulatory and labeling burdens to bear, however.

When can detection sensitivity cloud the issue?

So the question becomes, when does greater testing sensitivity provide greater clarity, and when can it obfuscate the issue of determining whether something is ‘safe’ or not?

“The advent of using mass spectrometry techniques has greatly increased the reliability and sensitivity of analytical methods,”​ James Neal Kababick told NutraIngredients-USA. Neal Kababick is the founder of Flora Research Laboratories​​ in Grants Pass, OR.

“In all cases one must take into consideration the levels of the compound and how it relates to ingredients in general. Dose makes the poison. If you go low enough you can find toxic compounds in all sorts of things. Therefore you must take into consideration the big picture,”​ he said.

“With the instrumentation we have we can find very low levels now,” ​said Andrea Wong, PhD, senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition​​. As a trained toxicologist who before her stint at CRN worked for a regulatory consulting firm, Wong has had long experience in deteriming the safety of products.

“Even the products that tested the highest for levels of arsenic ​(in the protein study) are far below the amount of arsenic you’d get from a can of tuna or even from bottled water,”​ she said.

“When you look at the vast majority of the test results the numbers were very, very low. You have to look at what we are exposed to in our everyday lives,” ​Wong said.

Disagreement about long term risks

Neal Kababick said there is a lack of clarity about the safe harbor limits for long term exposure to some toxins. But he disagrees that there is a looming public health crisis.

“Just reporting any presence of lead as a bad thing does not help. It is only creating confusion and clouding the issue,” ​he said.

Fabricant disagreed with the characterization that FDA is asleep at the switch when it comes to long term toxicity.

“FDA is the gold standard for food safety worldwide. If there is a better, safer good system in the world, go ahead and show it to me,”​ he said.