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How to Write FDA Compliant Copy

Guidelines for Compliant Copywriting


Compliance with FDA regulations is a serious business. Food and drug companies must ensure that their websites meet FDA expectations when describing their products' benefits, which generally means including more information than the prospective customer may want. The FDA's regulatory expectations are evident when it comes to describing your product as you must include the name of the ingredient, its common or usual name, and its generic name. Next, explain how the ingredient functions in your product. Then, explain what exactly is in it, including a list of all active ingredients in descending order by weight with an inactive ingredient and source other than water listed after each active ingredient.


The Food and Drug Administration (FDA) emphasizes that any business should not say or imply that a supplement can in any way “prevent,” “treat” or “cure” any disease. Therefore, it is crucial to market your product with promotions and advertisements that will deliver a strong and compelling message so your readers will be convinced to buy. Not adhering to the specific guidelines of the FDA can jeopardize your business. In order to keep your business with their compliance guidelines, their website has kindly outlined their five principles to help keep your practices in line with their laws.


FDA Warning Letters

When the FDA determines that a cosmetic product is in violation of the FD&C Act or an applicable regulation, the FDA has the authority to issue a warning letter to the manufacturer or distributor of the product. The warning letter will typically inform the manufacturer of the alleged violations and instruct the manufacturer to detail the corrective action that the manufacturer intends to take. Usually, the response must be in writing and sent to the respective agency district office, as outlined in the received warning letter, within 15 working days. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure of products and/or injunction against continued manufacturing operations". For more information, visit the FDA's website and search their database of Warning Letters.


When writing a product description that meets the FDA's guidelines, transparency is key. Goop, a wellness and lifestyle company founded by Gwenyth Paltrow, has faced its fair share of FDA warnings. An example of one product that was flagged for its non-compliance is their Rose Flower Tincture Essence.

This is a product description that will serve as an example of non-compliant copy
Goop's Rose Flower Essence Tincture Product Page

In 2018, there was a lawsuit where Goop was prohibited from making false or misleading statements about nutritional supplements or medical devices and claims that its products can treat diseases without prior FDA approval. This particular product describes "cooling and moistening, it’s used in traditional Chinese medicine to combat yin-deficient heat—some of the manifestations being restlessness, insomnia, hot flashes, or hyperactive states; it’s even been used traditionally to help stop panic attacks". This product, like many others involved in this lawsuit its effects on consumers was all speculation, one product description going so far as to say "fans say that regular use increases hormone balance".


The FDA has made it clear that there must be scientific evidence to back up such a claim, and therefore Goop was in violation of the 2018 Stipulated Judgment that it entered into with the State of California by deceptively marketing products as having a therapeutic effect on several medical conditions. To read the full lawsuit by Truth in Advertising, click here.


When writing copy for a product in order to match the expectations of the FDA always refer to their 5 principles. Be truthful, do your research, and have evidence to back up anything you say your customers may benefit from.


 

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