Frank Jaksch, founder and chief scientific officer of ChromaDex, an Irvine, Calif.-based proprietary ingredient manufacturer, knows from the inside what’s entailed in making consistently high-quality supplement ingredients and finished products.
As part of their due diligence, Jaksch recommends that retailers ensure the dietary supplements they sell:
- Meet GMP requirements
- Have had all ingredients 100 percent identity tested
- Be free of contaminants
- Meet the minimum specification for potency
- Have been thoroughly tested at every level of production
- Contain the appropriate amount of each ingredient for clinical effectiveness
Jaksch also advises asking manufacturers these questions:
- Are your products (or ingredients) certified by USP, NSF or other independent entities?
- Do you manufacture the products or do contract manufacturers make them?
- If a contract manufacturer is used, are actual contracts in place withthat company?
- Have you visited your contract manufacturer’s facility, and do youperform regular audits on that facility?
- Has the FDA inspected your or your contract manufacturer’s facility?
- Did FDA issue any 483s, warning letters or recalls after that inspection?
- If so, what actions were taken to address the issues?
- Do you use an independent lab to test the raw materials you source and your finished products?
- Do you test ingredients for identity as well as potency? If so, can I see the results?
- Are your lab’s testing methods up to date and scientifically validunder GMPs?
- Do you test for heavy metals, contaminants and adulterants?
- Have formulations—not just individual ingredients—been tested to ensure they are compliant with California’s Proposition 65 limits?
- Do you have specifications in place for all finished products?
- Do you test products as they are released?
- Do you perform stability testing?
- What criteria do you use in setting “expiration dates” for finished products?
- If you use a contract manufacturer, do you work with that company to set specifications and select raw materials for your finished product?