Company Fails to Pass FDA ‘Smell’ Test--Literally

Of all the ways to validate the identity and quality of ingredients used during the course of manufacturing, using your nose isn't among the most advisable.

That piece of wisdom was included in a recent Warning Letter sent by the US Food and Drug Administration (FDA) to a manufacturer of dietary supplements, NJ-based Herbalist and Alchemist, Inc.

FDA's letter indicates that the regulator had inspected the company between 22 October and 16 November 2013, during which time it found manufacturing deficiencies under 21 CFR 111, the Good Manufacturing Practices (GMP) regulation for dietary supplements.

In several instances recounted in the letter, FDA said its inspectors found that the company had failed to use an "appropriate" test or examination to verify the identity of the ingredients used to manufacture its supplements.

The key word there: "appropriate."

FDA noted the company had utilized "organoleptic testing" methods in the course of conducting quality control. Organoleptic refers to the qualities of a substance that can by experienced by sense, such as taste, sight, smell and touch.

In plain terms, the company's employees were reportedly trying to literally sniff out bad ingredients.

This, however, earned the ire of FDA. "An organoleptic test is not a sufficient test for an extract once it is removed from the botanical," FDA observed.

The company had defended its use of the organoleptic testing methods, saying it used the tests to screen for "off odors" that could indicate mold, rancidity or non-plant matter in the raw materials.

However, FDA took issue with this approach. "We do not agree that purity of a botanical ingredient can be determined by smell alone," it wrote. Regulators also noted that purity and identity cannot be determined by smell alone, and require more thorough analytical testing.

The company had reportedly tracked "aromatic aroma" as a proxy for purity for one of its ingredients. Similar test methods were noted, though the exact references were redacted from the report.

Elsewhere in its letter, FDA observed that "'faint, disagreeable aroma' is not a standard [test] or a specific test for purity."

The company was given 15 days in which to respond to FDA's letter.

 

Warning Letter to Herbalist and Alchemist, Inc