The Dietary Supplement Health and Education Act (DSHEA) of 1994 amends the Food, Drug, Cosmetic Act originally passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs and cosmetics.
DSHEA establishes “dietary supplements” as a new category of food with specific definitions of what constitutes a dietary supplement and provides FDA with the authority to mandate good manufacturing practice (GMP) regulations specifically for dietary supplements, section 3 and 9 respectively.
In June 2007, the FDA issued the final rule for Current Good Manufacturing Practices (CGMP) for dietary supplements requiring that proper controls are in place so that dietary supplements are manufactured consistently as to identity, purity, strength and composition.
Analytical Solutions for the Dietary Supplement Industry
This industry faces unique challenges when implementing analytical methods for testing identity, purity, strength and composition including:
- As defined by DSHEA, a diverse scope of dietary ingredients; and final products that may incorporate upwards of 25 different dietary ingredients in one product;
- Large product proliferation with many SKU’s as product versions are targeted to specific consumer markets such as vitamins for women, men, children or seniors;
- Dietary ingredients based on natural products, subject to variation of growing conditions and geographical sourcing;
- Short product development cycle and frequent product evolution as new dietary ingredients gain media attention and consumer interest;
- Complicated distribution channels for dietary ingredients, and risk of economically motivated adulteration, especially for expensive ingredients; or those in short supply.
Although no one analytical technique can solve all analytical problems, FT-NIR offers many benefits for dietary supplement testing programs including:
- Efficient supply chain management as routine operators can readily scan samples in seconds “as is’ with no sample preparation for pass/fail in a warehouse or in a lab
- Improved sampling plans – ease and speed of testing makes it possible to test more thoroughly rather than rely on a single sample pulled from a large container so that top, bottom or middle of container, or multiple drums from one delivery is quickly tested to ensure consistency of the entire delivery and to qualify suppliers
- Verify overall ingredient or product quality rather than relying solely on the tests on the certificate of analysis (COA), enabling rapid screening for economically motivated adulteration
- Archive spectral fingerprints of raw materials, in-process samples and final products to build business intelligence and provide traceability to avert frivolous litigation
- Streamline compliance with the dietary supplement cGMP regulations.
ID testing on incoming raw materials
The Dietary Supplement cGMPs require 100% identity testing on incoming raw materials. With no sample preparation, easy user interface and results in seconds, routine operators are able to rapidly pass/fail incoming raw materials, drum by drum if desired, with FT-NIR Spectrometers like MPA or TANGO. Spectral data is archived, building a detailed history of lot-to-lot variation by supplier, supporting supplier qualification programs as well as improving process efficiency through tighter control of input. FT-NIR methods are based on chemometric analysis of the spectra of reference standards and traceably tested lots that define mathematical pass/fail criteria, eliminating operator interpretation and making it suitable to screen for economically motivated adulteration (EMA) and subpar quality.
Quality testing from input to output ensures safe supplements, efficient supply chain management and optimized processing. Raw Material suppliers also rely on FT-NIR to strengthen their relationships with their clients and to protect the integrity of their deliveries.