Did you know that 40% of all dietary supplement companies checked by the United States Food and Drug Administration (FDA) last year were cited for manufacturing process violations and received the terrible Form 483? That’s a bad rap for any supplement company, and it’s a blow to their credibility and reputation.
You might be wondering, what does this mean for supplement companies? How does the FDA control dietary supplements? How do brand owners ensure that they comply with the legal regulations governing supplements and supplement labels so that they do not run afoul of the FDA?
Being the best fish oil supplement manufacturer in the USA, Icelandirect frequently receives questions from supplement brand owners about the regulatory structure in the nutraceutical industry and how to avoid common blunders. We are here to answer all of your questions and will explain the regulations of the FDA.
Is the FDA in charge of dietary supplements?
They are, indeed. It is important to note that, while the FDA does not evaluate dietary supplements for safety and efficacy before they are marketed. The FDA strictly regulates the ingredients in dietary supplements. As a result, it is essential for supplement brand owners to ensure that their marketing adheres to established product and packaging standards and that their manufacturing abides by cGMP necessities for dietary supplements.
What has been viewed as a cGMP (current good manufacturing practice) violation?
Failure to follow any of the steps outlined in the FDA’s regulation of nutraceuticals in the United States, as stipulated in 21 CFR Part 111, lays the groundwork for regulatory violations.
What exactly is an FDA Form 483? What impact does it have on the supplement industry?
When an investigator(s) observes any conditions that, in their opinion, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts, an FDA Form 483 is approved for the supplement company after an inspection.
FDA Form 483s are open to the public and can be obtained through the FDA’s Freedom of Information Act Office. As a result, anyone can request and obtain a Form FDA 483, which is then made available to the public. Eventually, this can be detrimental to the reputation of a supplement company.
Why should supplement brand owners avoid FDA citations, warnings, or actions?
Even though FDA-issued citations, warnings, or actions indicate that you are not in compliance with the regulations, which is a serious matter, some of these citations, warnings, or actions (like Form 483) are listed on the FDA’s website. This means that your dirty laundry will be accessible to anyone, including your customers and competitors.
What are the possible consequences of an FDA citation?
At extreme bad, the FDA can order a product recall, seize a product, prohibit its sale, and even shut down a facility. However, they are more likely to necessitate corrective action on the part of the supplement company. Failure to take the suggested corrective action can have far-reaching consequences.
How can supplement companies guarantee that their products remain FDA compliant?
Having a Quality Assurance Department (even if it only has one person) is a great way to help verify that a supplement brand’s business/products remain FDA compliant. Another option is to work with an experienced supplement manufacturer, such as Icelandirect, which is cGMP certified and has an in-house QA department that assists in adherence to dietary supplement regulations.
Icelandirect holds a variety of certifications for the importation of fish, salmon, and other marine oils for human and pet consumption. Iceland is our primary source of fish oil because it consistently produces the highest quality fish oils available anywhere.
We offer services like bulk manufacturing, on-demand order fulfillment of supplements, custom formulation, private label, and many more. We have delivered the best fish oil supplements in the USA for the last 10 years. Visit us now!