Consistent, Compliant Dietary Supplement Testing
Certified Laboratories offers supplement 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 labs meet your testing needs, including specifications testing 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 or raw material into your facility, you need to be confident that it’s exactly what you ordered. Current Good Manufacturing Practices (cGMPs) 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 100% identity testing for all dietary ingredients, raw materials, and finished products to confirm identity and determine whether other specifications for components are met.
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.
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.
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.
CONTAMINANTS
Dietary supplements 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.
Supplement Testing to Meet Amazon Requirements
In addition to testing to help you meet U.S. FDA requirements, our supplement testing labs also conduct most of the tests 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.
Highlights of our supplement testing capabilities are listed here; contact us if you don’t see what you need.
Amino Acids
- 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
- Testing for all plant-derived herbal products, including dried oils and 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
- Degradation details help to confirm products are rugged throughout their shelf life.
Enzymes Analysis
- Measurement of key enzymes such as amylase, protease, and lipase to ensure product efficacy.
Fatty Acids Testing
- Complete nutritional profiles for all fatty acids, including Omega 3, Omega 6, Omega 7, and Omega 9.
Method Development & Validation
- Design scientifically valid and fit–for–purpose methods unique to your product and matrices that address the problems you are looking to solve. Designed for accuracy, precision, linearity, ruggedness, specificity, and applicable quantitation limits.
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 scientists use a variety of methods depending on the requirements of the matrix and the specifications of the sample. We can also develop a method for your matrices when compendial methods are not available. Our methods for supplements testing include…
AOAC, AOCS, USP, FDA BAM, and other scientifically validated methods
3,000+ compendial methods
2,000+ in-house methods
Client-provided methods
Certifications & Accreditations
Certified Laboratories is a fully compliant cGMP/GLP testing facility following the 21 CFR 111 sub J and ISO 17025 standards.
Burbank, CA
Formerly Micro Quality Labs
- FDA (21 CFR 210, 211)
- ISO 17025 – Biological
- ISO 17025 – Chemistry
- DEA
- Health Canada
Carrollton, TX
Formerly Microconsult
- FDA (21 CFR 210, 211)
- ISO 17025
- ISO 9001
- DEA
- Health Canada
Tustin, CA
Formerly ABC Testing
- ISO 17025
Instruments for Supplement Analysis
Our dietary supplement testing labs use the most appropriate instruments for your analysis to produce trustworthy, accurate data, including the following:
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 the complex and confusing regulatory landscape for dietary supplements can be overwhelming for manufacturers. 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 are one of the leading supplement testing companies available. Contact us now to get a quote for your dietary supplement lab testing needs.