FDA’s CBER Issues Six Untitled Letters to Laboratories, Contract Manufacturer

Posted 07 October 2015 | By Zachary Brennan 

FDA’s CBER Issues Six Untitled Letters to Laboratories, Contract Manufacturer

All six of the identical untitled letters from the US Food and Drug Administration (FDA) to companies making licensed allergen mixtures deal with the companies’ failure to use “correct and consistent nomenclature” on their websites.

The letters from Mary Malarkey, director of the Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research, were sent 25 September to Oklahoma City-based Allergy Laboratories, Washington-based contract manufacturer Jubilant HollisterStier, Missouri-based Antigen Laboratories, North Carolina-based Greer Laboratories, San Diego-based Allermed Laboratories and Texas-based ALK-Abello.


In each letter, FDA warned the recipients for failing to disclose the proportions of non-standardized extracts used in licensed allergen mixtures.

“The inaccurate identification of the proportions of non-standardized extracts used to make licensed allergen mixtures can lead to mistakes in the diagnosis and inappropriate treatment of allergies,” FDA says.

And in order to avoid misbranding charges, FDA says that consistent use of identifying terminology and correct identification of the proportions of each non-standardized extract used to make licensed allergen mixtures are necessary.


As far as its reasoning behind these letters and claims, the agency points to reviews by external panels of data related to the safety, effectiveness, and labeling for non-standardized allergenic extracts in 1974-1979 and 1982-1983. The first panel’s report proposed that specific designations and identifiers for the source materials be used and that these appear on the product label for all allergenic extracts. The second panel further specified that genus/species names be used to identify pollen, mold and plant extracts.

FDA also formed an internal committee to review available scientific and medical data from published literature on the safety and effectiveness of non-standardized allergenic extracts, finding that the nomenclature was not consistently applied.

For example, manufacturers have multiple listings in the licenses for allergenic extracts derived from the same source material.

That review became the basis for the nomenclature provided in each of the letters to fully and accurately identify licensed non-standardized allergenic extracts, and FDA notes that technology is available to accurately identify the species of all source materials used for allergenic extract manufacture.

FDA also provided in its letters the proper identifiers for source materials of non-standardized allergenic extracts.

Moving forward, the agency is requesting the companies use the nomenclature identifiers provided in this letter and notify CBER on: (1) the steps they have taken or will take to properly identify the non-standardized allergenic extracts that are not identified, or properly identify the proportions of non-standardized extracts used to make licensed allergen mixtures, or both; (2) proposed timeframes for submitting labeling supplements and (3) plans to update establishment registration and product listing information including all currently manufactured products.

Letter to Allergy Laboratories

Letter to Antigen Laboratories

Leter to Allermed Laboratories

Letter to ALK-Abello

Letter to Jubilant HollisterStier

Letter to Greer Laboratories

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