Demystifying The COA-FS Brouhaha – The Name calling And Mudslinging Against The FDA Must Stop!
If laws are made to be at the comfort exercise of our convenience without recourse to consequences for not applying them ,then the society as a whole is on a top speed to destruction.
The FDA has a Safety Monitoring Department that derives 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 has a mandate to protect the public, and we should allow and support them to do their job! Let us take a step back and leave out the emotional stuff and let the FDA do what is required of them!
MODE OF DETECTION
Now, if one submits an application to register a product as a food supplement, there is no need for clinical trials. This is a standard registration procedure. Once the active ingredients are known (herbs listed), you get a market authorization after toxicity tests have been done to ascertain safety profiles. These were all done and the product passed! The fact that a product has passed such tests does not mean the FDA is done with their job. They have a responsibility to monitor every product on the market. Postmarketing surveillance (PMS) (also post market 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.
It was during one of such monitoring episodes that the FDA detected microorganisms in more than one batch of the product and immediately notified him to recall the product. Unfortunately, he didn’t comply and resorted to an outmoded strategy of pitching the public against the FDA.
Microbial contamination of pharmaceutical products is a common problem which has been reported and dealt with professionally. Contamination of Pharmaceuticals with micro-organisms can bring about changes in their physical characteristics, including the breaking of emulsions, the thinning of creams, fermentation of syrups, and appearance of turbidity or deposit, besides producing possible off odors and color changes
COA-FS & THE FDA
“It’s like they are trying to collapse the company. The fact that two bags of the product was contaminated does not mean all the products in the market was not good for our consumers”… Prof. Samuel Ato Duncan, The Chief Executive Officer of COA Herbal Center said in an interview on April 22, 2020.
The above statement is not only fallacious but absolute ignorance or complete misunderstanding of the point the Food and Drugs Authority (FDA) is making.
Microbial contamination can degrade products or, more concerning, can infect and injure patients. According to globally accepted food safety standards, dietary supplement ingredients should be entirely devoid of Escherichia coli, Salmonella, Staphylococcus aureus, or Clostridium species!
These are some of the bugs identified in COA FS on the Ghanaian market. A strain of E coli, O157:H7 is very dangerous. This strain causes severe diarrhea leading to renal damage and other serious complications including death.
Now, if one capsule (not even a bag/containerjust one capsule) shows microbial contamination, you will have to pull the batch off the shelves and if more than one batch is implicated, you will 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! This is normal practice for all regulatory organizations around the World.
Pharmaceutical product recalls occur on regular basis all around the World and there are stringent conditions for manufacturers to satisfy before such products are allowed on the market again. These tests are made in accredited labs with the requisite standard checks. In the event that bottle samples, of the same content exhibit different test results what are the implications? Is it not a potent call up for all bottle contents back to the lab amidst further investigations?
Dietary supplement contaminated with bacteria/fungi/mold/yeast have been linked to to soo many aggravated health concerns.
With all our checks on this matter, we disagree with the argument that the FDA is being too harsh on the manufacturer of COA FS. Yes, COA FS may be an immunebooster supplement and served many purposes but before you jump to their defense and say negative things about the FDA under the underlying circumstances of the matter, please ask yourself if you will knowingly take a contaminated drug or give one to your child!
God continue to bless the CEO and staff of the Food and Drugs Authority for saving Ghanaians from another casualty if not an epidermic.
Credit: Victor Wutor
Signed
*PARROT COMMUNICATIONS*