3 Most Common Violations Nutritional Supplements Manufacturers Make
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Dietary supplements are consumable products regulated by the FDA or the Food and Drug Administration. We, as a Chinese dietary supplement ingredients supplier, will receive FDA warning letters and penalties if we breach Good Manufacturing Practices (GMP).
These warning letters will ask the nutritional supplements manufacturers to rectify all the breaches they have committed.
If the manufacturer can not rectify the outlined breaches, the product can get taken off the shelf, and the producer can face huge penalties, such as license cancellation.
In this blog, we will mention the most common violations that dietary supplement ingredient suppliers commit.
Mis-branding and Mis-labelling of Products
The FDA has outlined that any supplement manufacturer who does not properly label its products will receive FDA warning letters. These claims are known as health claims.
You need to know that all health claims get reviewed by the FDA. As per The Food and Drug Administration, a health claim has two elements: a substance and a condition. If a statement does not have any component of two, it does not meet the FDA regulations.
There are also regulations for supplement manufacturers to label their products that are prone to allergies. Many nutritional supplements manufacturers fall victim to these FDA regulations and commit critical violations that lead to penalties.
Violation of Manufacturing Practices
It is one of the biggest traps that most manufacturers fall into. Good Manufacturing Practices, or GMP, are vital to FDA regulations. Many manufacturers feel guilty about not following the FDA practices and are penalized.
According to the FDA violations norms, food and beverage and dietary supplement manufacturers are at the top position on the list for failing to meet FDA manufacturing practices, the set standards, and production controls.
Lack of Documentation
FDA requires manufacturers to keep and provide a hard copy of the documentation for all manufacturing practices. You need to provide written evidence to prove you are loyal.
If a manufacturer follows all the recommended protocols, it is necessary to have written data to prove that you are following all the regulations.
The FDA wants supplement ingredient suppliers to show all available data that concludes that the supplement is fit for the human body.
The manufacturer is also responsible for informing the FDA. And give all the records if it inserts any new ingredient or changes the existing supplement.