GMP Basics & Black Walnut Hull Allergen Labeling

This week’s WLW brings us back to GMP basics and a black walnut hull labeling question. Let’s see what we can learn.

FDA inspected this herbal supplement company from May 12 through June 8 of this year, which is a lengthy inspection period. At the end of the inspection, FDA issued a 483, and the company never responded. This is a big mistake and greatly elevates the risk of a warning letter.

From warning letter. “your firm’s “Receiving and Component Analysis” document for the component Mexican Sarsaparilla Root in powder form, botanical name of Smilax officinalis, under “Gross Organoleptic Analysis” states that you confirm the identity by evaluating appearance (whole/cut/powder), color (light brown, reddish brown to pale brown), taste (mucilaginous, bitter, weak), and aroma (sweet, spicy). However, because other sarsaparilla-producing Smilax species share the same or similar organoleptic characteristics, including appearance, color, taste, and aroma, analysis of these organoleptic factors does not provide unique information specific to Smilax officinalis and therefore cannot, by itself, confirm the species-level identity of Smilax officinalis.”

Asa comments: Organoleptic testing can have a place in botanical identification. But the method needs to work for the ingredient and its form. For example, identifying a whole botanical and identifying a powder have different levels of complexity. In my contract manufacturing years, we’d always have organoleptics, such as “brown acrid powder,” on specifications, but this does not substitute for qualified scientific tests, such as HPTLC.

Microscopy can also be a valuable tool for helping identify powdered botanicals. Shout-out to Steven Yeager, Roy Upton, Elan Sudberg and American Herbal Products Association (AHPA) for providing hands-on botanical identification training.

From warning letter. “You failed to establish limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement… Specifically, you have not established limits on contaminants such as microbes and heavy metals that may be present in your dietary ingredients.

Asa comments: This is one of the basics of specifications. Listing contaminant levels gives QA guidelines for what is okay and what is not, and corresponding SOPs should direct the staff in how to handle out-of-specification results.

From warning letter. “Our investigator observed residual dietary ingredient powder remaining after each encapsulation cycle which was being collected in a … container for reuse in subsequent capsule production using a worn brush and other tools. The manufacturing employee stated that these tools were reused across production runs and cleaned between uses by spraying … and wiping.

Asa comments: Running an encapsulator is no easy task. Seriously, hug your encapsulation operators!  However, it seems like proper cleaning between product runs was not taking place. We used to categorize our cleaning protocols as major and minor. Major cleans took about a day to wash, dry, and reassemble and were saved for major allergens or after messy products such as turmeric. Minor cleans required some disassembly, but using validated non-residue cleaners and air often did the trick; we never left residue on anything, and this was documented for a QA sign-off before each run.

Question for you: How are you approaching allergen labeling for black walnut hulls? FDA lists black walnut as a major food allergen, but its guidance states that labeling requirements for ingredients from other plant parts depend on whether they contain protein from the major allergen. In an additional comment in this warning letter, FDA states that the company’s Black Walnut Hulls product does not declare the required allergen. Some companies add a separate “Contains walnut” statement, while others identify black walnut in Supplement Facts. Where do you stand on this?

See the warning letter for FDA’s comments and the other GMP lessons.

Allergen Guidance