How to Respond to FDA Warning Letters: A Guide for Supplement Companies

HomeHow to Respond to FDA Warning Letters: A Guide for Supplement Companies

How to Respond to FDA Warning Letters: A Guide for Supplement Companies

By Will Cartwright | | 0 Comments | 14 March, 2019

All supplements are created for a specific purpose. Ethical companies will manufacture and label their supplements in the correct manner to fill that purpose.

Unfortunately, there are unethical companies that have in the past and are still trying to manufacture supplements with dangerous ingredients, in a dangerous manner, labeling their supplements with faulty claims or leaving out important information that the consumer needs to know.

For this reason, the FDA monitors supplement companies closely to ensure that they are following the necessary steps to manufacture a safe supplement with truth and full disclosure on their labels. When the FDA finds that a company has failed to meet these standards, they will send them a warning letter.

This isn’t to say that every company that receives an FDA warning letter is unethical, because the rules and regulations to comply with by the FDA are very numerous and complicated. Therefore, there are FDA attorneys who study these laws thoroughly to help companies understand and comply with them.


FDA laws and regulations


Unfortunately, even with the best of intentions, some companies will still receive FDA warning letters when unknowingly failing to meet the FDA regulations. There is a step by step process that should be followed by a company if they have received one of these letters.

Types of FDA Warning Letters

There are several different reasons that a company could receive an FDA warning letter and the letter itself should clearly state the reason behind the violation. The five categories of incompliance are:

  • unapproved ingredients- This is when a supplement includes ingredients that have not been approved by the FDA.

  • false labeling- This is when the label of your supplement claims to have something that it does not or doesn’t disclose all the ingredients.

  • Misbranding- There are many ways that a product is guilty of misbranding. They include failing to label with name and place of business, inadequate directions of use, failing to include warning against use by a certain group of people, etc.

  • improper manufacturing processes- This is when you don’t follow the approved method of manufacturing of your products by the FDA. These approved methods are called CGMP, or current good manufacturing practice.

  • failing to meet mandatory labeling requirements- This is when you label lacks something that the FDA considers a mandatory part of the labeling process. This could be different for liquids, capsules, and powders. It could be different depending on the chemical nature of the product.

    There are many factors that can change these regulations. It is always best to have your finish product checked and pre-approved by the FDA.

Once the FDA becomes aware of a company’s incompliance to regulations, they will send a warning letter explaining the actions they found that were against FDA regulations. The letter will instruct you to stop the manufacturing of the product in question until compliance can be proven.

Of course, stopping production of a certain product can be very detrimental to your company but there are steps that you can take that will help you to lessen this time period.

How to Proceed After Receiving an FDA Warning Letter

The first step in the process to continue operations after receiving an FDA warning letter is to fully understand the violations you are being accused of and what actions you allegedly made to be in violation.

Again, FDA rules and regulations are very complex. It is advised that you meet with an FDA attorney to have them explain the manner of correcting these violations.

Once you fully understand where the problem lies, you can make a plan together with your attorney to fix the problem. This plan should be written out in a letter along with a timeline you anticipate will be needed in order to carry out this plan and sent to the FDA as a reply to the warning letter.

You only have 15 days to reply to an FDA warning letter, so time is of the essence. If you fail to meet the deadline, your product might be seized, put on recall, or be ordered to stop production and sale of the product.


don't get a product recall


Common FDA Warning Letters for Supplement Companies

The supplement industry has a certain parameter of rules that the FDA applies to them. Often, it is within these rules specific to the supplement industry that companies will fail to comply because the line is so thin between compliance and incompliance.

Many times, it could just be a certain wording used in the advertising of supplements or failing to get FDA approval ahead of marketing.

Dietary claims- This is a big area of concern for the FDA. Supplement companies must be very careful as to how they claim to benefit the body. In order to claim health and disease benefits, there must have been enough scientific proof that the supplement will in fact deliver on these claims. In order to label a supplement with these claims, the FDA must have time to pre-approve of the claim backed by scientific research.

Invalid Labeling- The consumer must be aware of all certain information by reading the label of your supplement. This information must include ingredients, nutrition, quantity of product, your business’ identity statement, etc. It cannot include any information that is misleading or omissive.

Prevent Receiving an FDA Warning Letter

Of course, the best thing to do is never receive a warning letter in the first place. All warning letters sent out are printed and posted on the internet for any consumer to see. In order to not be tainted by a bad name, the best thing to do is to be very diligent in complying with FDA regulations.

The FDA has many brochures and booklets that will break down all the laws concerning FDA compliance of supplement manufacturing, labeling, and marketing.

By having a good knowledge of these regulations, meeting with your FDA attorney regularly to be updated on any new regulations, and by keeping a close eye on your wording and labeling, you can prevent ever receiving an FDA warning letter.

It is always good business, as well, to have your finished product, labels, and marketing material pre-approved by the FDA in order to ensure complete compliance.

Will Cartwright

Written by Will Cartwright

Will is a master of digital marketing in the vitamins & supplements space. He has years experience selling supplements on Google, self-hosted websites, Amazon, Facebook and much more. CLICK HERE to learn more about how Will can help your nutraceutical brand dominate digital marketing.

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