Sexual Drug Adulterations Testing

As many of our customers have been aware, Amazon recently requires that all nutrition

supplements with an indication of sexual enhancement (or male drive) on its labels and

promotion marketing material are required to test for three erectile dysfunction (ED) drugs,

Sildenafil, Tadalafil and Vardenafil, and two analogs of the ED drugs: Sulfoaildenafil, and

Desmethyl carbodenafil in its testing program. A similar requirement for testing weight loss

drugs has also been in place.

MS Bioanalytical has been providing testing certificates to our customers for dietary

supplements since the Amazon program started early this year. We now provide certificates of

analysis for testing ED and weight-loss drugs. To meet the requirement of the Amazon program,

we use LC/MS/MS methods. Typical MS chromatograms are shown Figure 1. As can be seen the

standards of five ED drugs were separated with strong signals. The spikes of these drugs into the

sample were recovered well. None of the five drugs investigated was detected in the test sample.

Based on the test results, a Certificate of Analysis with “ND” (not detected) of these five drugs

along with all necessarily required elements, which includes our ISO-17025 accreditation

number and contact information is issued to our customers.

Figure 1. Typical LC-MS-MS graphs showing three chromatograms of each of the five drugs:

standard of the drug, sample, and sample with spike of the drug.

If we can be service to you to meet the requirement of the program or you have any question or

require additional information, please feel free to contact us.

New Requirements for Nutrition Products at Amazon

As Amazon is getting bigger and attacking more and more sellers of dietary supplements to its platform, new requirements will be implemented by February 2021. Once it is fully implemented, any dietary supplements sold on its platform that do not meet the new requirements shall be either removed from its site, and Amazon may suspend the seller from marketing products on Amazon, withhold payments to the seller, or even pursue legal action. These new requirements are:

• A Certificate of Analysis (CoA), from an ISO/IEC 17025 accredited laboratory. Each CoA must have been issued within the previous six months, be for product that is within its expiration date, and include the product’s name, batch/lot number, or date code of the product, name and address of the manufacturer or distributor, the name of each ingredient noted on the Supplement Facts Panel (SFP) along with quantitative analysis confirming that the product contains the amount of ingredients as noted in the SPF, and the units on the CoA matching the units as found in the SFP.

• Product images that must show all sides of the product label that include the name of the product, the name and address of the company, batch, lot number, or date code of the product and the SFP.

• A letter of guarantee from the manufacturer, on their letterhead the complete name of the product as it is represented in the product label and labeling; an assurance that the product has been properly manufactured under the Good Manufacturing Practices of 21 C.F.R. 111, an assurance that the product is not adulterated under Section 402(f) of the Federal Food, Drug, and Cosmetic Act and the assurance that the amount of ingredients in the product reflects what is represented in the SFP and is safe for consumption.

MS Bioanalytical is an FDA-registered and ISO-17025 accredited laboratory. Our service scope covers all areas of testing dietary supplements. Upon request, our CoA may be tailored to meet Amazon’s requirements with minimal cost for such CoA.

If you have any question or have additional requirements, please feel free to contact us at info@msbioanalytical.com, (217) 689-2969.

Cannabis Is legal In Illinois; Why testing Cannabinoids?

Illinois’ law for marijuana recreation use has just gone into effect January 1st statewide. This is the 11th state in the country that has made cannabis product legal for recreation use in additional to medical use. This was a big deal for Michigan that makes marijuana legal on December 1st 2019. It will be big as well for Illinois. However, it is still illegal at the federal level. FDA has yet to provide a guideline frameworks and interpretation of a Farm Bill- Agriculture Improvement Act of 2018. In this bill, cannabis sativa L (Hemp), which contains less than 0.3% of Tetrahydrocannabinol (THC) on dry weight basis, was removed from under the control of “Control Substance Act (CSA)”. This pays the way for people to use this crop that contains high concentration of (Cannabidiol) CBD as an agricultural product for consumption and recreational use. We are eagerly waiting for FDA’s move on the legal use of the hemp in the national level.

An important aspect for the creational use of cannabis product in the eleven states is to have strict quality control of the products. There are a number of key requirements that must be met for recreational use in Illinois: Cannabis products must be tested by a certified laboratory such as ISO-17025 accredited and approved lab by the Department for Agriculture of Illinois, to contain no more than the limit of THC and the label amount of the claim for CBD. In addition, the products must contain undetectable or below the legal limits of heavy metals, pesticides, microbial pathogens and mycotoxin.

MS Bioanalytical LLC (MSB) is an FDA-registered and an ISO-17025 accredited testing laboratory. We as a participant passed the Performance Testing (PT) for cannabinoids and have been providing tests of cannabinoids to our customers. The common testing procedure for cannabinoids is an HPLC method

MSB would like to help you in testing cannabis products. We offer fast turnaround time and competitive cost. We will go extra miles to make sure of your complete satisfaction.