It is complicated that what the FDA actually does with the supplement and what comments from the public are allowed by the FDA. It is going to be vital to get the messages for the agency and for the Congress. The FDA is known for not letting scientific information related to supplements and food to be shared. And now the FDA will not allow scientific research to be performed, and through some resources it has come to our knowledge that research on a few nutrients and supplements has already been paused.
Supplements Cannot Be Converted Into Drugs
According to the law, if publications on the studies about nutrients are done, people will not be allowed by the FDA to buy nutrients in the form of supplements. Even if any drug company has a plan to convert the supplement into a drug, they will not be allowed in the market because there is a ban on supplements. It is correct that the studied nutrients and supplements are not going to be available to the public, as according to the FDA, they can be transformed into drugs. This ensures that the drugs related to the FDA will not be in competition with supplements.
FDA’s Approval Process
If a nutrient is required to be approved, a lengthy and expensive process is to be followed, after which the supplement will be allowed to be used to prevent and treat a disease for which the studies have been done.
An Investigational New Drug (IND)application is to be submitted by a company if they think that the new claim of health can be supported by the studies they have done. Previously, food items and nutrients did not require INDs because the study does not show the planned use of the food product.
Why Research On Nutrients Is Important
- Research must be done on nutrients as it will be beneficial for us to learn their effects, and we can also come to know how they are potentially going to be used in the future. The general public gets information from the internet that is based on such research so they are aware of everything to make decisions about their health.
- Through the submission of new drug applications companies may publically claim that the drugs are marketed by them. Claims have always been made by medicinal foods about disease and the guidance means that an IND would be needed for all the medical foods despite of the filing of the notification of new dietary ingredient. The application for an IND is a must despite the NDI’s filing and the $2.3 million that must be paid.
- When research is made and then published, the nutrients will become drugs. This can result in stopping the studies which occurred to eradicate the access to the nutrient that is being researched. If an IND is filled out it will guarantee that when the research is published, the nutrient cannot be marketed as a supplement