It is a common misconception among people that dietary supplements are not standardized or regulated. This couldn’t be further from the reality. Dietary supplements are not drugs, and therefore, FDA regulates them in a different way. Supplements do not have to be approved by the FDA before they hit the market. Dietary supplements do not need a pre-market review by FDA. However, if the FDA finds misleading claims, substandard manufacturing practices or harmful ingredients, it can withdraw and ban the products to ensure consumer’s safety.
Dietary supplements can go through the same degree of testing and scrutiny as pharmaceuticals. In some cases, some dietary supplements go through a more rigorous testing process than some pharmaceuticals. To ensure their safety and effectiveness, certain regulations are in place.
- Companies are not allowed to make claims regarding prediction, prevention or curing of any diseases.
- FDA also restricts ingredients that can be added to the supplements and mandates removal of raw materials deemed harmful.
- But perhaps the most important factor when regulating supplements is the inspection of supplement manufacturing facilities by the FDA. FDA inspects manufacturing facilities to make sure that everything from quality and safety of raw materials to comprehensive testing carried out on supplements, is in compliance with the Current Good Manufacturing Practices (cGMP).
As with anything that is to be consumed by people, supplements need to be manufactured with great care and with the finest ingredients. Opting for a non-FDA registered facility can potentially put you at risk of getting supplements with substandard ingredients or ingredients that are diluted with a huge volume of carriers to reduce efficacy. Just choosing pure ingredients is not enough, the entire manufacturing process should be careful enough to not compromise the purity of the ingredients. Moreover, supplements need to undergo several tests throughout the manufacturing process to detect contamination.
Additionally, inappropriate climatic conditions of supplement manufacturing facilities can potentially compromise the potency and efficacy of certain ingredients, especially in liquid formulations. An FDA registered facility that works with supplements must always provide transparency in their manufacturing operation.
GMPs for supplement manufacturing is in place to make sure that the supplements being created are pure, efficacious and marketed as nothing more than what they can actually deliver. Choosing an FDA registered facility like Ion Labs will save you time and money. Details like outside third-party testing to ensure the composition and quality of supplements are services that are not always available at a supplement manufacturing facility. Ion Labs provides these resources to all custom formulation customers.
Periodic inspections from the FDA and larger clients help to ensure manufacturers remain compliant with their operational practices. FDA approval means that the facility is producing products properly and that they have the right amount of pure ingredients and can be trusted for effectiveness and safety. While a company must be FDA registered to manufacture supplements, delivering quality products, can build and maintain the trust of customers.
Registering with the FDA is no walk in the park. It means periodic inspections from the FDA to ensure that the facility is following current GMPs. Non-compliance with FDA regulations like using unregulated or unapproved ingredients or failure to label correct ingredients can result in warnings and cancellation of the FDA registration. Ever since the cGMPs were implemented for manufacturing vitamins, Ion Labs has been an industry leader in ensuring compliance.