The FDA on August 8 warned Redmond-based herbal supplement company Oregon’s Wild Harvest about quality control failures that could allow contaminants into their raw materials.

Oregon’s Wild Harvest, however, claims the Food and Drug Administration’s letter is misleading and leaves out critical information — that all contaminants were found and dealt with.

During an inspection Sept. 20-24, 2021, the FDA found raw materials at the company’s facility that included rodent feces, glass, hard plastic and a AA battery. Some of the allergens found included wheat, tree nut shells, peanut shells, corn, seeds and walnuts.

But Oregon’s Wild Harvest founder Pam Buresh, CEO Mark Vieceli, quality control manager Jacob Sausville and other quality control personnel said those contaminants were found and removed and none were ever sold to customers.

Mark Blumenthal, the founder and executive director of an independent nonprofit focused on research and education surrounding herbal medicine called the American Botanical Council, said it’s not uncommon to find and remove contaminants like this.

There can be all manner of contaminants from agricultural products that come straight from the field, he said. Some might include pesticides, heavy metals and insects or larger objects like nails, cigarette butts and plastic.

“It’s almost impossible to have agricultural products that are 100 percent (pure),” Blumenthal said.

Vieceli said removing contaminants is inherent in agricultural production and that other companies should be scared with the misleading nature of the FDA’s letter.

“It sounds like it got in the end product,” he said. “It never sold.”

The FDA said they’d received a response from the company and planned to re-inspect the facility in the future, but would not comment on the case as it remains under investigation.

Contamination

Records indicated that, in some cases, if the raw ingredients came to the Wild Harvests facility in multiple bags of the same lot, the quality control team would reject the bags with visible foreign materials, yet approve other bags. In other cases, the FDA wrote, the company appeared to approve bags after quality control used visual confirmation that foreign material was removed.

“Removing the visible foreign material may not ensure the absence of contaminants,” noted the FDA.

They highlighted one of Wild Harvest’s lots which was contaminated with wheat grains and how, even after removing the visible allergen from it, the material still tested positive for gluten.

The company, which manufactures dietary supplements like milk thistle, ginger and ginkgo capsules, uses whole agricultural crops in their products rather than powders — unlike most of their competitors.

Because of this, and like in the food processing industry, contaminants are common.

“The FDA acknowledges that this is unavoidable,” Vieceli said.

For example, peanut butter is allowed to contain an average of one rodent hair or 30 insect fragments per 3.5 ounces. Even the US pharmacopeia, an independent organization that sets quality standards for medicines and dietary supplements, allows up to 2 percent of foreign organic matter, Blumenthal said.

“Yes, we do find things,” Buresh said. “We do not send it out to our customers. We do not put it in our end product. We absolutely do not.”

According to Buresh, products at Oregon’s Wild Harvest get tested every step of the way. First when it arrives on the premises, then when it is sorted, milled, processed and packed into capsules. All machines used are disassembled, cleaned, sanitized and inspected. If at any point during the process a product does not meet their specifications, it is rejected.

Oregon’s Wild Harvest has been inspected three times by the FDA, but only found problems in its most recent inspection. In 2019, Wild Harvest was ranked as the Portland Business Journal’s Manufacturer of the year for an organization of 51-100 employees.

Other issues

The company has responded six times since the first inspection, but the FDA said the responses have been insufficient and that Wild Harvest has failed to address a laundry list of issues outlined in the last year.

One such issue was an over-reliance on FTIR testing — a form of testing that analyzes the composition of their products on a molecular level. While FTIR is widely used, it cannot detect individual dietary ingredients in the company’s bulk blends.

Since then, the company says it has purchased and integrated a more powerful testing process that separates components in a liquid mixture and can better identify the composition of products.

Other violations included failure to use appropriate testing for microbial contamination and growth, placing “best buy” and “use by” dates on their products without data to back up these dates and failing to give specifications on the identity, purity, strength and composition of their products.

Oregon’s Wild Harvest mentioned that while the FDA was misleading with their quality control practices, the company acknowledged that paperwork was a stumbling block and something they needed to work on.

“It was really around our documentation that we had to be more clear on,” Vieceli said.

“Our paperwork was a failure,” Buresh said. “It really sums up the whole majority of it. It was our paperwork.”

Buresh and Vieceli added that they are working on fixing their documentation processes to meet the FDA requests.

According to Blumenthal, dietary supplements require an extremely detailed amount of paperwork with very technical documentation required for every piece of the process.

“Small businesses have a difficult time with this,” he said. “It’s extremely taxing from an overhead and time perspective.”