Bee Pollen Company Cited for Inadequate Specifications
Importance of a quality management system
This is a precautionary tale on how to correctly set up a product testing program, run a quality management system, and how to avoid a warning letter. A bee pollen dietary supplement company received a warning letter for incomplete product specifications and inadequate 483 responses.
Quality control (QC) must review and approve/deny product specifications. QC is a gatekeeper that prevents ingredient issues from reaching the product, which is a core aspect of GMPs. It seems the company was using specification sheets, but did not have a Pass/Stop/Review section. “Trust but verify” and “If it’s not written down, it didn’t happen” are critical parts of GMP compliance.
From warning letter. “Your quality control personnel failed to approve or reject component specifications that may affect the identity, purity, strength, or composition of a dietary supplement… For example, you provided the FDA investigator raw ingredient specifications for Domestic Bee Pollen Powder Bulk, Foreign Bee Pollen Powder Bulk, and Foreign Bee Pollen Granules Bulk. However, the specifications did not include documentation to support that your quality unit approved or rejected the specifications.”
Finished product specifications can sometimes be difficult to fully comply with. This is understandable if an expensive custom identity and composition method must be built for each formula. However, doing something is better than nothing, especially since the incoming raw materials were also dinged for having no identity specifications.
From warning letter. “The label claim for your Bee Pollen product is 3g Bee Pollen, and the label claim for your Royal Jelly product is 268mg Royal Jelly and 99 mg Bee Pollen. However, you did not establish specifications for the identity, purity, strength, and composition of the Bee Pollen Granules 16 oz and Royal Jelly 1000 mg 60ct capsules.”
FDA visited the facility in April 2025 and issued some 483s. Later in the month, the company provided 483 responses that FDA deemed inadequate. There seems to be no other communication until the warning letter was issued seven months later. This seems to be a trend: FDA issues 483s for GMP issues such as product specifications, the company provides incomplete responses, and several months later, a warning letter is issued. This is a friendly reminder that providing complete 483 information and maintaining good communication with the FDA Compliance Officer are essential to compliance and to avoiding these darn warning letters. Many of these GMP-related 483s can be addressed before they lead to warning letters, in my opinion. Read the warning letter to see how “incomplete” the 483 responses were. This company needs help!
Labeling issues are mentioned in this warning letter, which provides an important reminder about serving sizes. The serving size in the SFP must match the maximum amount consumed at one sitting. One capsule, up to 2x daily = a one capsule serving. Take 1-2 capsules daily = a two-capsule serving.
From warning letter. “The directions of use suggest the consumer take “1-2 capsules once daily” but the serving size lists 1 capsule.”
As a side note, I love royal jelly and bee pollen as part of my supplement regimen. I’ll need to buy here in New Zealand! I will also be bringing back Manuka honey, a go-to for immune and goodness support in my house.
Read the warning letter here.
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