The consumption of dietary supplements continues to rise within the United States and in 2013, Americans spent approximately $34.9 billion on supplements.
Based on new Dietary Supplement GMPs, dietary supplement testing and 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 opportunities. As a result, CPT℠’s dietary supplement testing processes have expanded along with the growing industry.
Although dietary supplements do not receive the same regulation as OTC or pharmaceutical drugs, their testing standards are becoming more strict.
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 dietary supplement, view pre-market testing as a requirement, not an option.