Ensuring Quality of Organic Dietary Supplement Ingredients

Sales of organic dietary supplements have experienced double-digit growth for the last few years, and it seems this strong growth trend remains on track for the next five years. With this growth comes the need for comprehensive and stringent quality control (QC) programs to assure identity, integrity, quality and safety of organic ingredients.

Most, if not all, quality-related questions can be answered by evaluating the cultivation and harvesting practices, the manufacturing practices and the QC program adopted by the ingredient suppliers. A quality dietary supplement is one that uses the correct plant species and plant part, and is both unadulterated and safe for human consumption. The organic identity of the ingredient should be preserved during all phases of sourcing, manufacturing and distribution.

Passing the Tests

Different types of identification methods such as macroscopic, microscopic, organoleptic, Thin Layer Chromatography (TLC), High Performance Liquid Chromatography (HPLC) an d Fourier Transform Infra Red (FTIR) may be used to identify the genus, species and plant part. Each of these identity tests has advantages and limitations. The type of identification method used should be specific enough to differentiate between the species and plant parts. In most cases, a combination of different methods is required to identify the plant species and plant part beyond a reasonable doubt.

Beyond identity, ingredients should be tested for pesticide, heavy metal and aflatoxin contamination. Overall quality of the product, such as insect filth, foreign matter, etc., should also be evaluated. Chemical tests are also required, to confirm the material meets the claimed potency of active or marker chemical constituents. Depending on the type of the chemical constituent, different instruments such as HPLC, GC or UV spectrophotometer may be used to quantify these chemical constituents.

No matter how good the testing, however, organic botanical supplements face an inherent challenge, as the nature of herbs makes them susceptible to contamination by microorganisms. The environment in which the herbs are grown, harvested, handled, dried, stored and transported affect the amount and type of microbial load in herbs. Some such microbes could be pathogenic and potentially unsafe for human consumption.

Good agricultural and collection practices in every phase of the growing, harvesting and handling phases ca n minimize the microbial load. However, some form of sanitization is usually required to lower the microbial load to safe levels.

Several different sanitization options are available. But it is important to understand the regulatory and quality impact of such sanitization processes prior to choosing one that is appropriate for the specific product. For instance, ethylene oxide (ETO) has strong antimicrobial properties and has been shown to be effective in reducing microbial load in plant based materials. However, it is considered a potential carcinogen and leaves a residue in the product. ETO is, therefore, not suitable for organic products. Another highly effective but controversial method is irradiation.

This, too, is not suitable for organic products.

Steam sterilization is a viable option for organic products and is becoming more popular. Dry steam sterilization has been found to be as effective as ethylene oxide and irradiation in reducing microbial load. Unlike ETO and irradiation, the process does not leave any residue, is completely natural and environment friendly, has minimal impact on physical and chemical properties of the herb, and is organic.

The quality of t he herbal products is also affected by the manufacturing process. Cross contamination with other products, co-mingling with non-organic products, environmental contamination, mix-ups and mislabeling could lead to poor quality and/or adulterated material.

These can be avoided by implementing GMPs (good manufacturing practices) and Hazard Analysis Critical Control Points (HACCP). Lack of adequate control or training regarding these essential steps can lead to costly mistakes.

A key step in ensuring the quality of finished organic dietary supplement is choosing an ingredient supplier that will provide material that meets all requirements. Not only does the ingredient need to be organic certified, but it should also meet regulatory, identity, purity and safety specifications. The vendor should be provided with the detailed ingredient specification so they can fully understand the requirements of the customer. The specification should be a part of the contract between the customer and the supplier. The customer and supplier should agree on the ingredient specification prior to placing or accepting orders.

Organic certification does not necessarily equate to high-end quality, but it does indicate a commitment to higher standards. It takes recordkeeping, quality control and process controls a few steps further. 

Rupa Das is vice president, global quality & compliance for BI Nutraceuticals (www.Botanicals.com), where she is responsible for developing, implementing and managing the quality assurance, quality control and regulatory systems. She has developed and implemented a quality surveillance program for BI’s China group. Das has more than 13 years of quality and regulatory compliance management experience in the dietary supplement and personal care product industries.