Are herbal remedies regulated for safety?
Written by
Stella Nilsson
Reviewed by
Prof. Graham Pierce, Ph.D.Regulatory oversight for herbal remedies varies greatly around the world. In most countries, herbal products don't require the pre-marketing approval process that other medicines are subjected to. They tend to fall under post-marketing surveillance systems, where the onus for safety is on the manufacturers, rather than prior approval testing.
United States (FDA)
- Regulated as dietary supplements under DSHEA 1994
- No pre-approval required before marketing
- Manufacturers must ensure safety and accurate labeling
- FDA monitors adverse events through MedWatch system
European Union (EMA)
- Traditional Herbal Medicinal Products Directive applies
- Simplified registration for products with 30+ years use
- Requires proof of traditional use and safety
- Mandates product standardization and quality control
Third-Party Certifications
- USP Verification ensures purity and potency standards
- NSF International certification confirms ingredient accuracy
- ConsumerLab independently tests products for quality
- Good Manufacturing Practice (GMP) compliance required
Because the government doesn't always monitor supplements, independent organizations do third-party quality certifications. That's why you should look for the USP, NSF, and/or ConsumerLab seal to ensure that the ingredients on the label match what's actually in the bottle. Third parties confirm the characteristics of each ingredient and test products for contaminants, such as heavy metals, pesticides, and microorganisms, that regulatory oversight may have omitted from their monitoring.
Report suspected adverse reactions through channels such as the FDA's MedWatch (or the EU's EudraVigilance system). Keep any original packaging that contains the batch number so you have a record. Your reports help identify dangerous products and may also improve standards and policy for the general public.
Before buying a herbal remedy, consumers should research the brands. Specifically, look for transparency regarding the brand's sourcing and testing methods. A reputable company will provide Certificates of Analysis, asserting the purity and potency of every batch of the products they sell.
Read the full article: Essential Guide to Herbal Remedies
