The regulation of manufacturers that produce consumable products falls under the FDA or The Food and Drug Administration. FDA warning letters are issued to manufacturers that are found guilty of noncompliance with the established FDA regulations. The list of consumable products regulated by the FDA includes:
1- Dietary supplements
2- Medical devices
3- Personal care products and cosmetics
4- Food and beverages
All those manufacturers associated with the production of the above-mentioned products will receive FDA warning letters and penalties if they are breaching Good Manufacturing Practices (GMP). These warning letters will ask the manufacturer to rectify all the breaches that they have committed, while also outlining the nature of the breaches. The warning letter can be issued for several malpractices such as below par manufacturing practices and the product not performing how the manufacturer claimed it would. The letter also provides the timeframe that is provided by the FDA to the manufacturer to rectify the problem. What happens after the FDA warning letter is the FDA allows a certain window to rectify the problem. If the manufacturer is not able to rectify the outlined breaches, the product can be taken off the shelf, inventory can get seized and the manufacturer can face penalties such as their license being canceled.In this article, we will outline 3 of the most common violations that dietary supplement manufacturers commit.
Misbranding and Mislabeling of Dietary Supplements:
The FDA has outlined serious consequences for any dietary supplement manufacturer who does not properly label its products. Any dietary supplement that does not do what it says is violating the FDA regulations. Such claims are known as health claims. We can define health claims as the relation between a food substance (in our case a dietary supplement) and how it reduces a health-related condition. All health claims are reviewed and authorized by the FDA. As per FDA and by definition, a health claim has two components: a substance and a condition (disease). If a statement does not have either of the two components, it does not meet the FDA regulations. No health-related claims should be misleading. The FDA also inspects whether the substance/disease relationship is established in all health-related claims by carefully examining available scientific literature.
There are also regulations by the FDA for dietary supplement manufacturers to clearly label any ingredients that may cause allergies. These allergens may not have been directly used in the product but are being used for some other product manufactured in the same facility. Many dietary supplement manufacturers fall victim to the above mentioned FDA regulations and commit critical violations that result in penalties.
Violation of Good Manufacturing Practices:
This is by far the biggest trap that the majority of dietary supplement manufacturers fall into. Good Manufacturing Practices (GMP) is a vital component of FDA regulations that spans over multiple industries. Many manufacturers are found guilty of not following the processing and production controls and are penalized.
Although GMP is applicable across various industries, according to the FDA violations database, food and beverage and dietary supplement manufacturers top the list for failing to meet FDA compliance, the set standards, and production controls. The reason for this is that dietary supplement manufacturing involves the usage of raw materials that are perishable. The most common violations are unsanitary conditions of the manufacturing facility and the use of potentially harmful ingredients. Dietary supplement manufacturers should be careful that they do not commit these violations.
Dietary supplement manufacturers should make sure that they establish checkpoints at every stage of production and religiously follow Current Good Manufacturing Practice (cGMP) protocols.
Lack of Recordkeeping and Documentation:
FDA enforcement requires dietary supplement manufacturers to keep and provide written documentation for all manufacturing practices. The archiving of product process information is one of the major regulations outlined by the FDA. The need to provide documented evidence that a manufacturer is following all the recommended production protocols is necessary as this data enables the FDA to prove that you are following all the regulations.
The FDA requires manufacturers to provide all available data that concludes that the product is fit for human consumption. The manufacturer is also bound to inform the FDA and provide similar data records if it decides to add any new ingredient or make changes to the existing product.
False labeling on supplements with fake GMP logos is also one of the most heinous and criminal acts that most supplement manufacturing companies and sellers commit. There is a dire need to put an original and legitimate logo on supplements for all sellers and manufacturers. At PureNSM, we are offering the opportunity to all certified supplement brands to set their products apart from the fake ones by putting an honest and reliable “VeriGMP” logo on it.