Alkemist Labs Warns Dietary Supplement Industry of Falsified Documents

Alkemist Labs Warns Dietary Supplement Industry of Falsified Documents

Tuesday, June 2, 2020
Written By: Joel Villareal

Alkemist Labs recently made a strong warning to the dietary supplement industry of falsified documents, particularly Certificate of Analysis (COA) lab reports.  It appears that dietary supplement companies are altering the COA report that laboratories, such as Alkemist Labs, have issued or used portions of a COA report and copied and paste into a different document.  From an obvious regulatory perspective, this is a violation of good manufacturing practice as codified in the regulations.  In addition, this is fraud.  This means that the finished product with the questionable component will be considered as adulterated.  Adulterated dietary supplements will definitely increase the chances of harming and/or injuring consumers of said products.

Quality is the most fundamental aspect of cGMP, especially for dietary supplements.  According to the GMP regulations for dietary supplements, the definition of quality is consistently meeting “the established specifications for identity, purity, strength, and composition, and limits on contamination.”  In the situation regarding altered COAs, the quality of the products has been compromised because we do not know if all components, most especially the dietary ingredients, have been truly tested for quality.  In an example from Alkemist Labs, there was a questionable report brought up by some of Alkemist Labs’ contacts that apparently identified an elderberry botanical extract.  However, Alkemist Labs was able to determine that the COA report associated with the component was changed or made up because they have specific guidelines of what their COA report should look like.  A sketchy COA report is definitely a red flag and should be investigated further.  Because of this altered COA report, the quality of the component as well as the finished products that used this component cannot be confirmed.

The fraudulent activity of falsifying documents such as COA reports is absolutely dangerous to the consumers.  It is the responsibility of the dietary ingredient suppliers and dietary supplement companies to ensure all products meet all quality specifications.  Consumers expect a certain ingredient or dosage when they purchase a dietary supplement product.  Unfortunately, the only information they will see is what is in the label and not the actual documents going into the product.  It is agreeable with Alkemist Labs that falsifying COA reports is becoming more common due to supply chain limitations.  The commonality is disturbing because that means more components and products out there are made with potentially dangerous ingredients.  If there is a questionable document from a supplier, then it is in the best interest of the dietary supplement companies to be proactive and qualify their suppliers and test the component to ensure that the product they receive is what it is supposed to be in accordance with the regulations. 

Alkemist Labs has a valid warning.  A falsified document is never accepted in the FDA world.  It is a very serious noncompliant activity in cGMP.  A compliant dietary supplement supplier must have a robust quality unit that oversees any product release process.  That includes ensuring that the product meets all criteria for quality.  This type of document will definitely lead to regulatory activity such as 483 observations, warning letters, and recalls.  It is understandable that companies need components, but it behooves the company to work with a supplier that provides documents that are truthful.