In a letter recently posted on the warning letter portal of the US Food and Drug Administration, the Agency detailed the many quality control failures observed during an inspection of the company’s facilities in September 2021. The company responded to FDA’s concerns on five occasions, but the responses were deemed inadequate, which resulted in the issuance of the warning letter.
According to the warning letter, the inspection of the company’s facilities, which are located in Redmond, OR, and a review of its documentation found many causes for concern.
Contaminants picked out, lots subsequently approved
For example, on a number of occasions contaminants, potential allergens or foreign material including tree nut shells and/or peanut shells, bits of hard plastic, glass and rodent feces and in one case a stray AA battery were found in lots of incoming herbal materials. Yet at least portions of these same lots were passed by the company’s quality control personnel and were used in the manufacture of finished dietary supplements.
The warning letter indicates that the company had a practice of removing visible offending constituents from incoming lots of material and assuming that the rest of the batch was good to go.
“Your investigation for Milk Thistle Seed COG Whole component lot (b)(4) contaminated with wheat grains demonstrates that (b)(4) removing the visible allergen from the component does not necessarily completely remove the allergen from the component. The material tested positive for gluten after the manual removing of visible grains. Note that foreign materials, such as allergens, broken glass, and rodent feces, may not be evenly distributed in the components and that the presence of visible foreign material may be an indicator of gross contamination. Removing the visible foreign material may not ensure the absence of contaminants,” the warning letter stated.
Inadequate testing procedures
The warning letter also found many shortcomings in the company’s testing procedures. For example, the company reportedly used Fourier transform infrared spectroscopy (FTIR) to test batches of herbal blends while at the same time admitting to the inspector that this technology cannot detect individual components in blends.
In a subsequent response the company said it would reduce its reliance on FTIR testing to only ‘purified’ materials and to employ more HPLC testing, but did not provide a “scientifically valid method to ensure that the identity and strength specifications for all of your finished dietary supplements are met.”
The warning letter also alleged serious shortcomings in the company’s procedures for testing for microbial contamination.
Wild West?
Attorney Ivan Wasserman, partner in the firm Amin Talati Wasserman, had this to say:
“The company, Oregon’s Wild Harvest, is aptly named as the Warning Letter is evidence that the Wild West side of the dietary supplement industry is still alive and kickin’. It reads like a “most wanted’ poster of GMP violations.
“Perhaps the most important takeaway for the industry is the reminder of the absolutely critical importance of how you address FDA’s post-inspection observations. Thoroughly, promptly, and appropriately addressing them, being precise in your communications and meeting all commitments, is key to avoiding a Warning Letter or worse.”
Company response
Oregon's Wild Harvest responded that it does not believe that letter accurately conveys the company practices or how it makes its products. Specifically, OWH’s inspection and quality control procedures ensure that the only material that is in its finished product is what is supposed to be there.
“Most companies that sell herbs start with powders delivered by suppliers, and how those are handled and tested are not the same as for raw herbs.” said Pamela Martin-Buresh, Co-Founder. “Manufacturers that start with raw herbs are less common. Raw herbs are different from powders and from chemicals and their evaluation at the raw material stage is very different and perhaps not as well understood.”
“Raw agricultural commodities commonly contain some foreign matter,” said Michael McGuffin, President of the American Herbal Products Association. “The safety and quality issues for finished products are not whether foreign matter is present in the herbs and other agricultural materials received in a food manufacturing operation – especially when received directly from farms or wildcraft operations – but whether the company removes these prior to use as food or dietary supplement ingredients, and rejects any portion of a lot that cannot be reconditioned under cGMP rules.”
The company said the first step in its inspection process of producing herbal products is to carefully inspect each lot of material to remove foreign material. In the rare cases that the material is contaminated and cannot be reconditioned or doesn’t meet the company's quality standards, that container is rejected.
