Prop 65 Testing for FDA compliance
Reliable prop 65 testing designed for FDA compliance. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
Quick Answer
Prop 65 Testing for FDA compliance ensures products meet the specific regulatory and quality standards required for market entry. ISO 17025 accredited laboratories like Qalitex provide validated testing methods, detailed COA reports, and expert guidance to support fda compliance processes efficiently.
Achieving fda compliance requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides prop 65 testing tailored for fda compliance requirements. California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act) requires businesses to provide warnings before knowingly exposing consumers to chemicals on the Prop 65 list. Qalitex Laboratories provides targeted Prop 65 testing to determine whether your products require warnings, protecting your brand from enforcement actions and consumer litigation. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your fda compliance process.
How Prop 65 Testing Supports FDA compliance
FDA compliance requires documented evidence of product safety and quality. Qalitex provides the specific testing and documentation needed to support your fda compliance process, including detailed COA reports, method validation documentation, and expert consultation on testing scope. Our ISO 17025 accreditation ensures your results are accepted by regulatory bodies and marketplace platforms.
What Is Prop 65?
Prop 65 lists over 900 chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm. The law applies to any product sold in California, regardless of where it is manufactured. Non-compliance can result in private attorney general lawsuits, fines up to $2,500 per day per violation, and mandatory warning labels.
What We Test For
We test for the most commonly cited Prop 65 chemicals in supplements and personal care products: Lead (MADL: 0.5 μg/day), Cadmium (MADL: 4.1 μg/day), Mercury (MADL: 0.3 μg/day), Arsenic (inorganic, NSRL: 10 μg/day), Acrylamide, Di(2-ethylhexyl)phthalate (DEHP), and Bisphenol A (BPA).
Safe Harbor Testing
If test results show your product's exposures fall below Prop 65 MADL or NSRL thresholds, you can sell in California without a warning label. Our testing reports include exposure calculations comparing results against Prop 65 limits, providing documentation for your safe harbor defense.
Key Tests & Methods
Applicable Standards
Industries We Serve
How It Works
Three simple steps to your results
Submit your samples
Ship samples to our Irvine or San Diego laboratory with your order form.
Testing & analysis
Our ISO 17025 accredited scientists run validated test methods.
Receive your CoA
Get a signed Certificate of Analysis within 48–72 hours.
FAQ
Frequently Asked Questions
What testing is required for fda compliance?
FDA compliance typically requires identity testing, purity analysis, potency verification, and contaminant screening. The exact panel depends on your product type and target market. Qalitex Labs can recommend the appropriate testing scope for your specific fda compliance needs.
How long does testing take for fda compliance?
Standard turnaround at Qalitex is 5–7 business days, with rush 48-hour service available for most test types. We recommend planning testing 2–3 weeks ahead of your fda compliance deadline to allow for any retesting if needed.
Is Qalitex Laboratories ISO 17025 accredited?
Yes. Qalitex Laboratories holds ISO/IEC 17025 accreditation, the international standard for testing and calibration laboratories. This ensures our methods, equipment, and quality systems meet the highest standards of accuracy and reliability.
What is your turnaround time?
Standard turnaround is 5–7 business days. Rush service with 48-hour turnaround is available for most test types. Contact us to discuss your timeline requirements.
What types of products do you test?
Qalitex tests dietary supplements (capsules, powders, gummies, liquids), cosmetics and personal care products, food and beverage items, botanical extracts, and raw materials. We serve brands, contract manufacturers, and Amazon FBA sellers.
How do I submit samples for testing?
Ship your samples to our Irvine or San Diego laboratory with a completed sample submission form. We provide prepaid shipping labels for qualifying orders. Results are delivered electronically via secure portal.
What is California Prop 65?
California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act) lists over 900 chemicals known to cause cancer or reproductive harm. Any product sold in California must either test below safe harbor levels or carry a Prop 65 warning label.
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