Oct 27, 2023

What if wrongly created messages of branding become the reason of downfall of any organization?- Part II

What USFDA says about misbranding?

Yesterday in part I we discussed about misbranding.

There are few more reasons as per USFDA according to those a device’s labeling misbrands the product if:

  • It does not comply with the color additives provisions listed under Section 706 of the FFDCA (Federal Food, Drug and Cosmetic Act );
  • The device's established name (if it has one), its name in an official compendium, or any common or usual name is not prominently printed in type at least half as large as that used for any proprietary name;
  • The establishment is not registered with FDA as required by Section 510 of the FFDCA and has not listed the device as required by Section 510(j) of the FFDCA or obtained applicable premarket notification clearance as required by Section 510(k) of the FFDCA;
  • The device is subject to a performance standard and it does not bear the labeling prescribed in that standard;

What is False or Misleading Labeling?

As per USFDA Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular.

As if the labelling itself is misleading then it shall be prescribed & utilised in wrong purpose. And may lead to not giving the required results. The patient may not get recovery, may not be healed, Not only this but due to not getting the required medication it may be the reason of death in critical conditions.

Assignment for you.

In your organization check the labels of your products.

Check that what is discussed about your product is aligned with the actual or not.