DNA barcoding: Indena develops genomic identification method to protect botanical extract authenticity

17 Oct 2019 --- Adulteration within biomass materials sold for human consumption is increasing steadily, says pharmaceutical company Indena. In response to this, the company has developed DNA sequencing-based tests, or DNA barcoding, to assure the traceability of medicinal plants. This ability to guarantee product quality and safety follows years of research and investment. The company will be applying the new method to its bilberry extract Mirtoselect.

In order to combat ongoing botanical extract adulteration, the Italian company has added genomic identification and analysis to its quality control procedures in a targeted move to ensure the authenticity of its bilberry extract Mirtoselect. The company’s new method is made up of two crucial phases: purification and amplification.

First, the bilberry extract’s DNA is purified using an off-the-shelf kit. Second, a fragment of DNA is amplified using a real-time PCR-Probe which amplifies a specific region of the DNA to allow researchers to determine if the plant used to make the extract is actually Vaccinium myrtillus.

“The biggest challenge was finding a particular region of DNA to unambiguously identify the Mirtoselect extract,” Pietro Allegrini, R&D Director of Indena tells NutritionInsight. 

Product and ingredient adulteration is a serious concern throughout the nutraceutical industry, especially considering that dietary supplements usage in the US has peaked at an “all-time high,” with 77 percent of US adults reporting they consume dietary supplements, according to a Council of Responsible Nutrition (CRN) 2019 Consumer Survey on Dietary Supplements.

The new method is advantageous not only because it provides robust results, but also due to its speedy process. Amplification with a real-time PCR-Probe takes roughly an hour. “The PCR-probe based amplification allows a specific amplification of selected DNA. We validated our method by using other species closely related to that one of our interests and so far the method has never failed,” Allegrini affirms.

Besides this DNA analysis, Allegrini notes the company also performs chemical and physical tests according to the compendial monograph, potential contaminants verification as well as microbiological controls to ensure ingredient authenticity. 

Bilberry extracts are largely used in pharmaceutical and nutraceutical products due to their known positive effects on eye health and microcirculation. In terms of authenticity and product safety, it is of paramount importance to guarantee that bilberry extracts have the required specifications in terms of chemical components and of the declared pure botanical origin, Vaccinium myrtillus.

Adulteration within the nutraceutical industry
The American Botanical Council published a Laboratory Guidance Document on saw palmetto (Serenoa repens) extract to safeguard product safety and eliminate adulterated supplements from the nutraceutical market. Meanwhile, Arjuna invests a considerable amount of resources and finances to ensure that its BCM-95 Bio-curcumin extract is 100 percent traceable and protected against adulteration. “We have full control and system traceability from farm until delivery, with stringent quality checks protecting our product from adulteration,” Dr. Benny Anthony, Joint Managing Director at Arjuna previously told NutritionInsight. 

Natural Ingredients company Pharmactive Biotech Products is equally aware of the severe impacts adulteration can have within an extract line. It uses highly reliable techniques that are well-established for the genetic identity determination for its Spanish saffron extract, Affron. This aids in the detection of the presence of unwanted bodies and unauthorized ingredients. 

Amid industry moves to protect its ingredients from adulteration, recent US Food and Drug Administration (FDA) data found that only 2 percent of recalled supplements in 2019 were dietary supplements. The FDA notes that dietary supplements to support health are increasingly popular and the data indicates that regulations to protect consumers from unwanted side effects appear to be working effectively. 

Edited by Anni Schleicher