Regulatory Pitfalls That Supplement Brand Owners Need to Avoid
Did you know that of all the dietary supplement companies inspected by the U.S. Food and Drug Administration (FDA) last year, 40% were cited for manufacturing process violations and received the dreaded Form 483? That is a severe rap for any supplement brand and a blow to its credibility and image.[i]
But, what does this mean for supplement brands? How are dietary supplements regulated by the FDA? How do brand owners ensure that they stay compliant with the legal regulations of supplements and supplement labels so that they don’t run afoul of the FDA?
Armed with 43 years of nutraceutical industry experience and an incomparable passion for product quality, Gene Bruno, MS, MHS, RH(AHG), our Vice President of Scientific and Regulatory Affairs, answers these and a few more top-of-the-mind questions we regularly receive from supplement brand owners about the nutraceutical industry regulatory environment and how they can avoid making common mistakes.
What are the Most Common Regulatory Slipups by Supplement Brands? How Can You Avoid Them?
- Are dietary supplements regulated by the FDA?
Yes, they are. It is important to note that though the FDA does not review dietary supplements for safety and effectiveness before they are marketed, their ingredients and the finished dietary supplements are strictly regulated by the FDA. So, it is critical for supplement brand owners to ensure their marketing adheres to the established product and packaging specifications and manufacturing stays compliant with cGMP requirements for dietary supplements.
Watch Gene addressing this question in-depth in the video below.
- What constitutes a violation of the cGMP (current good manufacturing practice) requirements?
Failure to adhere to any of the steps laid out in the regulation of nutraceuticals in the U.S., as stipulated in 21 CFR Part 111 by the FDA, lays the base for regulatory violations.[ii]
- What is an FDA Form 483? How can it impact a supplement business?
An FDA Form 483 is issued to a supplement company at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA Form 483s are public information and are available through the FDA’s Freedom of Information Act Office. So, any Form FDA 483 can be requested by anyone and made available to the public. Clearly, this can hurt a supplement company’s reputation.
- Does a warning letter always follow Form 483? Why or why not?
An FDA 483 is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice only when the FDA notes a reason to take further action. You need to respond in writing within 15 days of receiving both a 483 and a warning letter. A warning letter is far more serious than a 483 observation. With a warning letter, any violations must be dealt with before you can continue to sell one or more products.
- What are the top areas of the supplement business/manufacturing that invite citations for FDA violations – for instance, finished product specifications, written procedures for quality control personnel, etc.?
- Claiming that your product can treat a medical condition such as Alzheimer’s disease, diabetes, etc.
- Product adulteration, including the illegal use of drugs in supplements, as well as the use of ingredients that are not considered to be “dietary ingredients.”[iii]
- Supplements being prepared, packaged or stored under conditions that violated cGMP regulations.
- What is the importance of establishing the following finished product specifications for supplement batches, and how do you ensure adherence?
- Identity – The identity of each ingredient in a product must be established to ensure efficacy and safety. This is accomplished in two ways:
- First, the ingredient or raw material supplier provides a Certificate of Analysis and a Specification which carries data about the identity, purity, and strength of that material.
- Once delivered to the contract manufacturer, the ingredient must undergo analytical testing to verify identity, purity, and strength. Likewise, a finished batch of a product should also undergo testing to verify the same.
- Purity – A raw material and the finished good must undergo testing for heavy metals and microbiological agents to verify safety.
- Strength – Alongside identity, strength testing must also be conducted on the raw material and finished product to confirm potency. This is important to assure product efficacy, especially where specific doses are required to impart specific benefits.
Composition – A finished product specification provides a formulation that identifies the product composition. This is necessary to ensure the inclusion of the correct amounts of
- Why should supplement brand owners avoid FDA citations, warnings, or actions?
Aside from the fact that FDA-issued citations, warnings, or actions are an indication that you’re not in compliance with the regulations—not a good thing—some of these citations, warnings, or actions (such as Form 483) are listed on the FDA’s website. This means that anyone, including your customers and competitors, will have access to your dirty laundry.
- Can FDA shut a supplement brand down or ban its products from being marketed?
Yes, under extreme circumstances, the FDA can take both actions if your committed violation is bad enough. However, it is more likely that the FDA would issue warning letters or seize products that they contend put consumers’ health at risk.
In the past, the reasons for doing the latter have included (among other violations):
- Dietary supplements being prepared, packaged, or stored under conditions that violated cGMP regulations.
- Other observed deficiencies such as a company failing to establish product specifications for the identity, purity, strength, and composition of each finished batch of their dietary supplement.
- Non-adherence to set limits on certain types of contamination (to ensure the quality of the supplement).
- Companies lacking written procedures for pest control and maintaining, cleaning, and sanitizing equipment or surfaces that came in contact with the dietary supplements.
The take-home message is to make sure your products are being manufactured in accordance with cGMP regulations. The best way to do this is to have them manufactured through a cGMP-certified facility, such as NutraScience Labs.
- What are the possible actions that can follow an FDA citation?
At worst, the FDA can force a product recall, seize a product, prohibit the sale of a product, and even shut down a facility. However, it is more likely that they will require corrective action on the part of the supplement company. Failing to take the suggested corrective action can lead to more dire consequences.
- How does an FDA citation impact a supplement business in the short term and the long term?
If the industry gets word of the citation, it may hurt the supplement company’s reputation in the short term, which, in turn, could negatively impact sales. The long-term impact is likely to be minimal if the supplement company takes corrective action.
- How can supplement brands ensure that their products stay FDA compliant?
Having a Quality Assurance Department (even if it is only one person in that department) is a good way to help ensure that a supplement brand’s business/products stay FDA compliant. Another way is to work with an experienced work with an experienced supplement manufacturer such as NutraScience Labs such as NutraScience Labs, which is cGMP certified and has an in-house QA department that helps ensure adherence to the dietary supplement regulations.
- How can NutraScience Labs help its supplement brand owners’ products stay compliant with FDA regulations?
NutraScience Labs has successfully manufactured, packaged, and labeled customized dietary supplement products for over 2,300 brands located around the globe. Furthermore, there has been no issuance of a Form 483 in association with any of these products. The bottom line is that NutraScience Labs has an in-house QA department with the experience and know how to help our customers stay compliant with FDA regulations. With 120+ years of collective nutraceuticals industry experience, there is no easier way to ensure your product and business integrity than choosing NutraScience Labs.
[iii] In order for an ingredient to be considered a “dietary ingredient” which is lawful for use in a dietary supplement, it must be approved as an NDI, an ODI or have GRAS status. An NDI is a new dietary ingredient which has been reviewed and approved by the FDA as safe for use in dietary supplements. An ODI is an old dietary ingredient with a documented history of use in dietary supplements prior to October of 1994. GRAS refers to an ingredient being on the Generally Regarded as Safe list which can be found on the FDA’s website.