The U.S. Food and Drug Administration (FDA) oversees the regulation of products, medicines, and foods that affect public health – and that includes products sold on Amazon. Even though a product may check all of the boxes – low competition, affordable manufacturing costs, high demand – the risks of running afoul of a federal agency may cancel out the rewards of selling FDA regulated products on Amazon.

As a general rule, anything that has not been cleared for over-the-counter use by the FDA or is considered dangerous by the FDA is barred from being sold on Amazon. But what about products that might or might not have FDA restrictions? Are derma rollers medical devices? Is hand soap a cosmetic? How can you be sure that your product fulfills both the legal requirements of the FDA and the selling policies of Amazon?

For private label sellers, understanding this information and integrating it into product research is crucial for avoiding disastrous financial consequences. Listen to our recent podcast for more details on selling in restricted and niche markets. 

Am I Selling FDA Regulated Products?

Generally speaking, the FDA is in charge of regulating foods, drugs and biologics, medical devices, electronic products that give off radiation, cosmetics, animal drugs, and tobacco products. Some of these products need FDA approval before being sold, and others do not. All of these FDA regulated products fall into Amazon restricted categories.

Categories that require the most regulation from the FDA – tobacco products, drugs, biologics, animal drugs and foods – are outright prohibited or require special permission to sell on Amazon. We will focus on products that do not need FDA approval and may be easier for private label sellers to market successfully.

Keep in mind that these products are restricted by Amazon and may have additional requirements other than those stated in this blog. Amazon takes restricted categories very seriously. If you list a restricted product without the proper FDA approval or complying to listing guidelines for that category, you could permanently lose your Amazon selling privileges.

Label Requirements

All Amazon products, even those that do not require FDA approval before being sold, must follow certain labelling guidelines:

• Labels must not state that the products cure, mitigate, treat, or prevent a disease (this includes conditions like dandruff and acne) in humans unless that statement is approved by the FDA
• Labels must not state that the product is “FDA Approved” if it is not FDA approved
• Labels must not use the FDA logo

The FDA logo is for federal government use only. Displaying the logo on a product, a product’s label, or a listing detail page may violate federal law and will likely lead to the removal of the listing from Amazon as well as to possible legal consequences.

Third party sellers must ensure that their manufacturer understands these Amazon labelling guidelines, especially since they often do not get a chance to see the finished product until it has already been manufactured. And though it may be tempting to use “FDA Approved” to advertise the safety and effectiveness of your product, misleading buyers can lead to negative reviews and returned orders, which in turn can cause your seller account to be suspended. It is always better to be open and honest about a product’s functionality and to rely on keyword optimization and advertising strategies, rather than false claims, to gather reviews and boost sales.

Medical Devices

All sellers are permitted to list medical devices that are authorized by the FDA for over-the-counter purchase that are not otherwise restricted and are appropriately described and labeled. All products that have not been cleared for over-the-counter use, are considered dangerous, or have been recalled by the FDA are barred from being sold on Amazon.

Medical devices that do not need approval and can be marketed by all sellers include:

• Eyeglass frames
• Tanning devices
• Otoscopes
• Ionized or ionic bracelets
• Personal Sound Amplification Products (PSAPs)

For sellers in the Professional Health Care Program, the list of permitted products is more extensive and includes Class I, II, and Class III medical devices that have been cleared by the FDA, like tongue depressors, powered wheelchairs, and some pregnancy tests.

Some products ride a fine line between being considered a medical device or not. Derma rollers, for example, are commonly used to treat acne scars. But the FDA considers any device that treats a disease or condition, like acne, to be a medical device. In addition, features like the length of the needles and method of use could cause a derma roller to be classified as a medical device. To avoid breaking FDA regulations, both the seller and the manufacturer must be careful of how they make and describe the product.

Dietary Supplements

Dietary supplements do not require FDA approval before going on the market. The only exceptions are supplements that contain a new dietary ingredient, in which case the manufacturers are required to notify the FDA at least 75 days before selling.

Amazon requires that supplements be correctly described and labelled. Most importantly, supplements cannot make structure-function claims on their labeling or listing, unless the claim has been approved by the FDA. Structure-function phrases make claims that the product can affect the structure or function of the body. This includes phrases like “reduces pain” “anti-bacterial” and “fights Parkinson’s Disease.”

If the label includes structure-function claims, the manufacturer must submit a notification to the FDA and include a disclaimer on the label that states the product has not been reviewed by the FDA and is not intended to diagnose, cure, treat or prevent any disease. Any content on the listing that includes these claims must also have the disclaimer.

Cosmetics

The FDA does not approve perfumes, makeup, moisturizers, shampoos, hair dyes, hair relaxers, face and body cleansers, shaving preparations, or ingredients within those cosmetics. The only ingredient that has FDA oversight is color additives (an extensive list of additives can be found here). The FDA also monitors reports of adverse reactions to these products.

Some cosmetics may count as drugs, and would therefore require FDA approval. Products that intend to make people more attractive are generally classified as cosmetics, but if a product intends to affect the structure or function of the skin or body, it is classified as a drug or even a medical device. Soap has its own set of definitions and may be monitored by a separate regulatory committee.

For example, Face Cream A claims to make people more attractive by making wrinkles less noticeable: it would be classified as a cosmetic. Face Cream B claims to remove wrinkles or increase collagen: it would be classified as a drug or a medical device. Even if Face Cream B could not actually remove wrinkles or increase collagen, the claim alone is enough to cause the product to be reclassified and fall under FDA scrutiny (this is why avoiding structure-function claims in your product listing is so important!)

Amazon prohibits the sale of cosmetics that have been determined to present “an unreasonable risk of injury or illness” to users. If you are unsure as to whether your product falls under this category, a complete list of prohibited items can be found in Seller Central.

Medical Foods

Medical foods are used to manage a disease or health condition that requires special nutritional needs. This includes gluten-free foods, but does not include meal replacements, diet shakes, or products for the management of diabetes which can be managed by modifying a normal diet. Medical foods are intended to be used under the supervision of a technician. If your food product is gluten-free but is not intended for the management of Celiac disease, it cannot be marketed as such and does not fall under this category.

The FDA does not have to approve medical foods before they are marketed, but medical food manufacturers must comply with other requirements including good manufacturing practices (GMP). Medical foods do not have to include nutrition information on their labels, but the same substance-function claim restrictions apply.

Final Thoughts on Selling FDA Regulated Products

Because private label sellers do not manufacture their products themselves, it is more likely that they will be penalized for not complying with Amazon restricted category listing guidelines rather than for going against FDA violations. But the FDA can take regulatory action if safety issues arise with a product after it has been sold, which could be disastrous for a seller’s reputation. These requirements are as much for the seller’s safety as for buyers.

All of these regulations prove just how important product research is to becoming a successful seller on Amazon. Of course, the easiest way to stay out of trouble would be to choose an unrestricted product that does not need FDA approval in the first place. Luckily there are millions of profitable products just waiting to be discovered.

If you decide to move forward with selling FDA regulated products, do not hesitate to reach out to us for market research tools, listing optimization services, and more. At Viral Launch, we want to provide you with all the information you need to become successful on Amazon. For more on Amazon selling strategies, we encourage you to subscribe to our blog, check out our Youtube channel, and listen to our Follow the Data podcast.