US FDA Nutraceutical, Dietary Supplement and Vitamin Testing

Today, ContractLaboratory.com received a request from a nutraceutical manufacturer bringing a new Non-GMO, vegan algae omega oil product to the market. As part of bringing this new product to market, they turned to us to help them find a laboratory that could perform complete certificate of analysis testing appropriate for an ingestable nutraceutical product. They were interested in NSF certification, vegan or American Vegetarian Association, non GMO Testing to include Fatty Acid Profile – EPA & DHA, Oxidation, Heavy Metals, Microbial Analysis.

This manufacturer was being prudent in performing testing and being in compliance with FDA regulations.  On August 4, 2015, the US Food and Drug Administration entered into a Permanent Injunction against 3 Wisconsin Dietary Supplement Manufacturers for failing to follow FDA Regulations.  These Dietary Supplement Manufacturers are The Atrium Inc., Aspen Group Inc. and Nutri-Pak of Wisconsin Inc. The FDA alleges numerous violations of the FDA’s GMP Good Manufacturing Practice regulations including failure to properly identify ingredients, failure to qualify suppliers and failure to properly manufacture and label products. These violations would cause the products to be misbranded and adulterated under the Federal Food, Drug, and Cosmetic FD&C Act.

Over the past 13 years, ContractLaboratory.com has helped numerous companies with the outsourcing of their nutraceutical testing. Below are just some examples of Projects that we helped on:

•  USA Analytical Chemistry Laboratory needed for natural extract testing: Formaldehyde detection using NMR ..
• Analytical Chemistry Laboratory needed for antioxidant capacity test done for a finished product containing capsules made of natural plant extracts and phytonutrients.
• Analytical Chemistry Laboratory needed for nutraceutical finished product testing for antioxidant capacity of finished product containing 45 capsules which is made of natural plant extracts and phytonutrients.
• India medicinal chemistry laboratory needed for analytical chemistry Testing of Diethanolamine and Triethanolamine in Moringa Leaf Powder
• Asia analytical chemistry laboratory needed for active compound testing 1. Erinacine A 2. Adenosine
• Analytical chemistry laboratory needed for supplemental analysis on my products (Nopal and Orostachys japonicus).
• Southeast USA contract laboratories needed for nutraceutical ingredient testing: Assay and heavy metals testing of raw nutraceutical ingredients. Ex. Creatine Monohydrate, Arginine Alpha Ketoglutarate 2:1, BCAA, D-Aspartic Acid, etc.
• Florida FDA GMP analytical chemistry laboratory needed for vitamin testing for Potency of Vitamin K-2
• India analytical chemistry laboratory needed for lycopene testing of lycopene samples from one of our supplier. Lycopene is available in synthetic form and also in natural lycopene from tomato .we need to test our sample is natural or synthetic.
• North America microbiology laboratory needed for microbiology challenge testing of sample of ionic silver (liquid) which we want challenged with these micro organisms FOR 28 DAYS- candida albicans, aspergillus niger, e coli, pseudomonas aeruginosa, staph aureus (MRSA) and enterococcus faecalis. On a separate quotation, please also provide the price for testing on listeria and salmonella
• Consumer Products laboratory needed for consumer product testing of dietary and muscle building supplements and skin care line such as moisturizers and anti-wrinkle creams to ensure all the ingredients are labeled properly, etc.
• FDA laboratory needed softgel testing to validate the following colors in softgel shell 1) Lycopene softgel: Titanium Dioxide, Caramel, 2) Multivitamin softgel: Titanium Dioxide, Carmine, FD&C yellow#5
• West Coast analytical chemistry laboratory needed to test a nutrition supplement for presence of amphetamine like substance, amount of synephrine (bitter orange extract) and the amount of caffeine.
• Analytical chemistry laboratory needed for selective androgen receptor modulator testing ..
• Asia FDA GMP Laboratory needed for dietary supplement testing: Finished Product Analysis & Accelerated stability studies for 1) Biotin – 10000mcg 2)Dehydroeplan Drosterore -25 mg 3)Turmeric(curcuma Longa) Blend – 500mg 4)L-Glutathione -500mg 5) Co Q10 – 300mg 6)Activated Vitamin C (Ascorbic Acid – 100mg Calcium Ascorbate -400mg)
• Los Angeles medicinal chemistry laboratory needed for natural preservative ting of natural preservative with 2 year shelf life
• Analytical Chemistry Laboratory needed to perform the following analysis in an herbal extract Food Supplement: – Carvacrol, – Safrole – Isosafrole – Furocoumarines. Additionally I would ask which would be the method used (in house method or any validated method) and the leadtime for analysis. I would require a quote, individualized for each substance

And many more! View Nutraceutical Laboratory Test Requests 

If you are a Nutraceutical or Dietary Supplement manufacturer or importer/exporter that needs to outsource it’s laboratory testing of it’s medicinal chemistry, vitamin, herbal or other products, please call us Toll-Free 1-855-377-6821 or SUBMIT LABORATORY TEST REQUEST