In a statement, the Pharmacists Forum said drug recalls all over the world are in the interest of public health and safety and urged those questioning the authority of the FDA to recall the batches of contaminated products to desist from the practice.

It said in global standard practice, if even one capsule shows microbial contamination, the company might have to pull the batch off the shelves and if more than one batch is implicated, it would have to pull the entire product from the market.

"The FDA may even ask for everything to be pulled off the shelves even if one batch was implicated and there is evidence to show failure in the quality assurance system. This is normal practice for all regulatory organizations around the World," the statement said.

The Forum said it was wrong for Prof Duncan to go testing samples in labs, which might not necessarily have the needed accreditation for such projects and using the resultant negative result to chastise the FDA.
It said the ability of a lab to perform tests that produce the accurate, consistent and reliable report is important in such analysis and it is public knowledge that the FDA's Microbiology lab which performed the test being contested by Prof Duncan is accredited to the ISO/IEC 17025-2017 standard by the ANSI-ASQ National Accreditation Board/ANAB of the United States of America.

This means that results from the FDA's lab can be relied on worldwide, it said.
Microbial contamination can degrade products or, more concerning, can infect and injure patients.
According to the US Pharmacopeia (USP), dietary supplement ingredients should be entirely devoid of Escherichia coli, Salmonella, Staphylococcus aureus, or Clostridium species.

Pharmaceutical product recalls occur on a regular basis all around the World and there are stringent conditions for manufacturers to satisfy before such products are allowed on the market again.
"Also, those who argue that the product should not have been approved initially for sale need to be aware of the protocols/procedures of FDA. Now, when one submits an application to register a product as a food supplement, there is no need for clinical trials," it said.

This is a standard registration procedure. Once the active ingredients are known/listed, you get a market authorization after toxicity tests have been done to ascertain safety profiles, adding that the fact that a product has passed such tests did not mean the FDA was done.

"They have a responsibility to monitor every product on the market. Post-marketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance," the statement added.
It was during one of such monitoring episodes that the FDA detected microorganisms in more than one batch of COA FS and also at the manufacturing plant and immediately notified the company with directions/guidance.

The FDA has a Safety Monitoring Department that derived their mandate to ensure the safety of regulated products from the Public Health Act, 2012, Act 851, Part 7, Section 125.

The Department is mandated to continually monitor the safety of the products regulated under the Public Health Act 851 by analysis of the adverse effect or event reports and by any other means and take appropriate regulatory action when necessary.

"Science may not have all the answers to our questions or problems, but we need to allow our institutions to work. The FDA is out to protect the public, and we should allow and support them to do their job," the statement added.