What Makes FDA Guidelines So Addictive That You Never Want to Miss?

[Adam Fleming]

What makes FDA guidelines so addictive that you never want to miss them? Well, FDA guidelines are something like the reminders for your car servicing. What happens when you buy a car? You get reminders from your dealer asking you to service it on time. The reason: your car is meant to be in fine shape when you drive it on the roads in real life conditions. What happens if you miss the service deadline? Nothing, except that you could be responsible for an accident which causes severe consequences.

Now, in this scenario, what if you had an idea of how much damage your car could cause in which type of accident? Would you still want to miss the servicing and checkup date? This is the summary of the principle of what makes FDA guidelines so addictive that you never want to miss out on them! Simple: just like how an inadequately serviced car or any other vehicle can lead to accidents and carry grave consequences for either the driver or the accident victim or both; having products in the market that don’t adhere to FDA guidelines has its costs.

Understand the reasons for which guidelines are issued

It is in everyone’s interest to ensure that products produced by companies in the regulated industries meet FDA guidelines. Their task will become a lot less tedious when they understand the importance of these FDA guidelines. After all, for whose benefit are these guidelines made? Is it for the FDA’s? No. It is for the benefit of the consumers, the organizations marketing these products, and for the general health of the public. When this is the rationale for which the FDA passes its guidelines, the imperative to meet these guidelines becomes clear.

To take the case of the example given here further, there is another very strong reason for which meeting FDA guidelines is addictive to the extent that you never want to miss them: stringent enforcement actions that follow from non-implementation. The FDA has prescribed strict penalties for different kinds of non-implementation of its guidelines. Its enforcement actions are carried out in the following four broad categories:

Warning Letters: The first and mildest of enforcement actions; a Warning Letter notes the violations the company may have committed and advises them on what action has to be taken to correct them.

Seizure: This action is about confiscating an adulterated or misbranded product and ensuring that such products do not enter the market or removing them if they already have.

FDA guidelines so addictive that you would never want to miss them! https://goo.gl/gzUxeX