Dietary Supplement Testing Lab for FDA, Amazon & cGMP Compliance
Certified Laboratories offers dietary supplement lab testing tailored to your needs. Through personalized service and direct access to our laboratory experts, we work with you to meet tight deadlines, with standard and rush TAT options available. Our ISO 17025-accredited and cGMP/GLP-compliant supplement testing labs meet your testing needs, including specifications for identity, purity, strength, and composition, helping meet regulatory requirements and support your safety and quality programs.
Dietary Supplement Testing to Meet U.S. FDA Requirements
When you receive a dietary supplement component, ingredient, or raw material into your facility, you need to be confident that it’s exactly what you ordered. Current Good Manufacturing Practices (cGMPs) for dietary supplements outlined in U.S. FDA regulations (21 CFR 111) require…
Verification that the finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement. Our supplement lab testing confirms identity, purity, strength, composition, and the absence of potential contaminants, per U.S. FDA regulations in 21 CFR 111.
IDENTITY
FDA cGMPs require identity testing for all dietary ingredients to confirm identity prior to use. You cannot rely on a supplier’s Certificate of Analysis (COA) and must perform identity testing yourself, which includes using a third-party supplement testing lab, such as Certified Laboratories. What’s more, the chosen method must unequivocally delineate the component from all others used at your facility. Our team can help you choose the appropriate supplement testing methods for your matrices.
PURITY
Dietary supplement ingredients and finished products must be free from adulteration and contamination, including pathogens, residual solvents, heavy metals, and other contaminants as confirmed through supplement purity testing. Microbiological tests are the most common for purity, but others are available. Talk to our team about which dietary supplement testing methods are right for your samples.
STRENGTH
The strength or potency of a dietary supplement is evaluated via the concentration, weight, or measure of each dietary ingredient and for the finished product. Strength must be confirmed prior to manufacturing. The method depends on the chemical nature of the analyte. For example, is it a vitamin? A botanical marker compound? A mineral? Multiple techniques can be used, such as HPLC, UHPLC, GC, etc. We can help you determine the best method for your samples.
COMPOSITION
Dietary supplement components include ingredients such as vitamins, minerals, herbs, amino acids, enzymes, and other ingredients, all of which must have defined specifications clearly articulated and documented in Master Manufacturing Records against which Batch Manufacturing Records will be evaluated. Composition testing may be physical or chemical, depending on the sample. Our supplement analysis labs can help you choose the right method for your matrices.
CONTAMINANTS
Dietary supplement components must be tested to ensure they are free from harmful contaminants like pathogens, pesticides, heavy metals, and residual solvents. Contaminant levels must meet FDA safety limits to prevent adulteration and protect consumer health. Many different substances can count as a potential contaminant, depending on the component being tested. Some may be vulnerable to, for example, pesticide residue, heavy metals, undeclared allergens, or other substances. We can help you identify for which to test based on your products.
Supplement Testing Labs to Meet Amazon Requirements
In addition to FDA compliance, our labs also provide most of the supplement testing required to sell your supplements on Amazon, including contaminant screening for heavy metals, microbial contaminants, and other analytes. We can also perform the testing required to verify product content claims and develop your Supplement Facts Panel.
Artificial Colors
- Blue #1, Blue #2, Green #3, Red #3, Red #40, Yellow #5, Yellow #6
- Matrices: gummies, powders, nutrient/protein bars or shakes.
Amino Acid Testing
- PDCAAS (Protein Digestibility Corrected Amino Acid Scores) for protein quality assessment.
- Identification and quantification of essential, conditionally indispensable, and non-essential amino acids.
Botanicals Testing
- Covers all herbal and plant-derived supplement products: dried, oils, tinctures
CBD Testing
- Accurate measurement of CBD content and identification of contaminants.
Contaminants Testing
- Comprehensive screening for pesticides, PCBs, mycotoxins, allergens, GMOs, residual solvents (Class I, II, III), heavy metals, and more.
Dissolution and Disintegration Analyses
- Evaluate product bioavailability, stability and breakdown over shelf life
Enzymes Analysis
- Measure key digestive enzymes like amylase, protease, and lipase for efficacy
Fatty Acids Testing
- Nutritional profiling for Omega-3, Omega-6, Omega-7, and Omega-9
Method Development & Validation
- Custom analytical methods designed for accuracy, ruggedness, and regulatory compliance
Microbial Analysis
- Detection of pathogens, such as E. coli, Clostridium perfringens, Listeria monocytogenes, Pseudomonas aeruginosa, Salmonella, Staphylococcus aureus, and more.
- Yeast & mold count
- Total Aerobic Plate Count
- Coliform Count
- Enterobacteriaceae
Minerals Testing
- Comprehensive analysis for a wide range of minerals, including Calcium, Magnesium, Iron, Zinc, Selenium, Potassium, and more.
Physical Examination
- Physical and sensory assessment, including visual and organoleptic evaluations, to ensure product consistency and appeal.
Probiotics Testing
- Our probiotic testing laboratory offers services for total probiotic count.
Stability & Shelf life Testing
- Expiration and “best by” dates based on microbial, chemical, physical, & organoleptic measures while correlating sensory degradation.
Vitamins Analysis
- Verified and validated data for the development of Supplement Facts Panels per 21 CFR 101.
- Testing for a wide range of vitamins to ensure compliance and label accuracy, including Vitamin A; Vitamin B1, B2, B3 (Niacin), B5, B6, B9 (Folic Acid), B12; Vitamin C; Vitamin D; Vitamin E; and Vitamin K.
Validated, Compendial, and Custom Methods
Our supplement testing labs use a variety of FDA-recognized testing methods to suit your needs:
AOAC, AOCS, USP, FDA BAM, and other scientifically validated methods
3,000+ compendial methods
2,000+ in-house methods
Client-provided methods
Certifications & Accreditations
- ISO 17025
- FDA (21 CFR 210, 211)
- DEA
- Health Canada
- cGMP/GLP
View our certifications and accreditations by lab location here.
Advanced Supplement Analysis Lab Instrumentation
We use state-of-the-art lab equipment to ensure high-accuracy, reliable supplement testing results:
FTIR Spectroscopy (Fourier Transform Infrared)
Direct UV
UV-VIS (Ultraviolet-Visible Spectrophotometer)
HPTLC (High Performance Thin Layer Chromatography)
HPLC (Evaporative Light-Scattering Detection) – MS, UV, ELSD
UPLC (Ultra Performance Liquid Chromatography) – UV, ELSD, MS
GC (Gas Chromatography)
LC/MS (Liquid Chromatography/Gas Chromatography)
PCR (Polymerase Chain Reaction)
ELISA (Enzyme-linked Immunosorbent Assay)
Regulatory Consulting for Dietary Supplements
Navigating FDA supplement regulations? We can help. From ensuring compliance with FDA regulations to maintaining cGMP standards, the path to market can be full of challenges.
EAS Consulting Group, a Certified Group company, offers expert guidance via its team of independent consultants, many of whom are former FDA personnel.
FDA registration and labeling compliance
cGMP audits and training
New dietary ingredient (NDI) notifications
Structure/function claim reviews
Dietary supplement safety assessments
Support with 21 CFR 111 compliance
Mock FDA inspections
Safeguard Your Supplements – Contact Us Now
We’re one of the most trusted dietary supplement testing labs in the U.S.
Contact us today to get a quote for your FDA-Compliant supplement lab testing needs.