What is an FDA warning letter?

FDA warning letter is a formal letter from the Food and Drug Association (FDA) of the United States Govt. to an organization or manufacturer for violation of any rules related to federally regulated activity. Being issued an FDA warning letter can be hugely damaging for any company.

What is the impact on your Supplement company if you don’t properly address it?

Has your supplement company received an FDA warning letter stating that the marketing on your website is not FDA compliant and that if you don’t change it you will be fined or worse yet, they will ban the sale of your supplement in the US? If so, you are probably panicking right about now. No doubt you are thinking that if you have to shut your supplement company website down, even for a short time, it will affect the Google ranking that you worked so hard to build up; and the longer your supplement website is inactive, the further down your ranking will plummet. At the same time, you are probably calculating how much revenue you will lose if your supplement website is down or if the FDA bans the sale of your supplement. If you don’t play your cards right, you could lose so much business that you have to close down.

How to make your supplement company website FDA-compliant?

Clearly, closing down is not an acceptable option. Here’s the problem though, you may have no idea what the FDA guidelines are, or what you need to change in order to comply with them. This can be a terrifying situation for any supplement company, but especially for smaller supplement companies that may not have FDA attorneys or PhD scientists on staff that know what to do. Please don’t panic; The Med Writers is here to help you. We are a team of PhD scientists with formal writing training, who specializes in writing marketing materials for supplement companies. We know what needs to be done in order to make your supplement company website FDA-compliant.

Making your website copy FDA compliant involves a couple of things. Firstly, and most importantly, you need to find studies that will substantiate the claims you are making about your supplement. Of course, not all studies will fit FDA guidelines; hence why you need someone that knows the FDA guidelines and is experienced in finding the right studies and writing FDA-compliant marketing.

A second thing that is involved in making your supplement company website FDA-compliant is knowing what type of wording is acceptable under FDA guidelines. For instance, oftentimes, words such as “cure” or “treat” cannot be used, unless there is substantial evidence to support those claims.

Of course, this presents another challenge; FDA-compliant wording can be limiting, and now that you don’t have the freedom to say exactly what you want, it can be more challenging to create convincing marketing materials. This is yet another reason why you need an expert on your side, someone that can work within FDA guidelines, but still, write convincing marketing copies complying with supplement marketing best practices.

If you’ve received an FDA warning letter, it doesn’t have to be the end of the world. Contact us right away so that we can start immediately on making your website and other marketing materials FDA-compliant.