Testing Dietary Supplements
The consumption of dietary supplements continue to rise within the United States and in 2013, Americans spent approximately $34.9 billion on supplements.
Based on new Dietary Supplement GMPs, supplement analysis ensures that each product meets strict restrictions based on efficacy and safety. Within the past decade or so, this sector has grown immensely and now provides plenty of opportunity. As a result, CPT’s℠ testing processes have expanded along with the growing industry.
Although supplements do not receive the same regulation as OTC or pharmaceutical drugs, their testing standards are becoming more strict. In fact, the FDA states that dietary supplements are regulated, and these regulations apply to both manufacturers and distributors.
The only way to ensure that a dietary supplement meets the requirements of the FDA and DSHEA (Dietary Supplement Health and Education Act) is to undertake supplement analysis. This analysis is required to evaluate safety and labeling.
How We Help Our Clients
When developing or reformulating a dietary supplement, we help our clients:
- Certify that the label on the bottle and the claims being made actually match the product inside.
- Ensure that the dietary supplement is safe based on toxicology reports.
- Thoroughly inspect their product to verify that no contaminants or undeclared ingredients are found within the supplement itself.
Unlike drugs, which need to be reviewed before the market, dietary supplements do not require pre-market approval. Despite this fact, pre-market testing is crucial in ensuring that a safe product is brought to market.
Dietary supplements must be manufactured under GMP to ensure the strength, identity, purity and composition of the product being sold. All health-related label claims must be properly substantiated and filed with the FDA 30 days prior to marketing.
If you launch a dietary supplement without proper testing of each active dietary ingredient appearing on the label the FDA could pull the product from the marketplace if it is found to be unsafe, or the labeling untruthful or misleading. Companies can also face stiff challenges from The Federal Trade Commission.
To protect your newly developed or reformulated supplement, view pre-market testing as a requirement, not an option.
Our capabilities at CPT℠ are vast, including:
- Vitamin, mineral and botanical assays.
- Validation services – including process, cleaning and water systems.
- Microbiology services – including USP methods, water testing, AOAC methods and microbial content.
- Claims validation – including human clinical studies, weight loss, tolerance studies and cosmetic claims.