This article is intended as a practical guide for sellers to address common product safety questions. Sellers are ultimately responsible for the safety and compliance of their products.
Friendly disclaimer: If you list products for sale on Etsy, you must comply with all federal, state, and local legal requirements and Etsy policies applicable to those products and product listings. This information provides an overview regarding non-exhaustive US requirements for educational purposes only, is subject to change over time, and is not legal advice. It's not intended to create, and receipt of it does not constitute, a lawyer-client relationship. The authors, Etsy, Inc. and Etsy Ireland UC disclaim all responsibility for any and all losses, damages, or causes of action that may arise or be connected with the use of or reliance on these materials. Requirements may vary depending on your location and where you make your products available. Please consult a licensed lawyer in your area for legal assistance.
What is a dietary supplement?
In the US, under Food and Drug Administration (FDA) regulations, a dietary supplement is a product taken by mouth that contains “dietary ingredients.” Dietary ingredients include vitamins, minerals, herbs or other botanicals, amino acids, enzymes, or other dietary substances (or extracts or concentrates of such ingredients). The purpose of dietary ingredients is to supplement the diet. Products sold as conventional foods or meal replacements are not considered dietary supplements. Dietary supplements come in many forms, including tablets, softgels, gelcaps, liquids, or powders. If your product meets this definition, regulations for how the product is formulated, manufactured, labeled, and promoted would apply, even if you do not specifically call or market your product a “dietary supplement.” It is your responsibility to understand what laws and regulations apply to your product. Etsy reserves the right to remove listings that may not meet applicable requirements.
Are there labeling requirements that apply to dietary supplements?
Yes. In the US, dietary supplements are subject to specific labeling requirements, and you may consider consulting legal counsel to ensure compliance with such requirements. Generally, dietary supplements must include the following information on their labels: (1) the name of the dietary supplement; (2) net quantity; (3) nutrition labeling; (4) an ingredient list; and (5) the name and place of business of the manufacturer, packer, or distributor. There are also limits relating to the claims you can make regarding your product, which are discussed below. For more information on these labeling requirements, please review the FDA’s guidance available here. We reserve the right to remove listings that may violate any legal requirement, including these labeling requirements, and to request any additional information necessary for us to assess compliance with our policies and with applicable requirements.
Are there ingredients that are not allowed in my product?
Yes. The dietary ingredients in a dietary supplement must meet a number of regulatory requirements. For example, there are restrictions for whether and how you can use dietary ingredients that were not marketed in the US in a dietary supplement before October 15, 1994. See FDA guidance on “new dietary ingredients” here. Additionally, it is your responsibility to make sure that all the ingredients in your dietary supplement or other ingestible product are safe. The FDA maintains a non-exhaustive list of ingredients that are not lawful ingredients in dietary supplements here and here. Etsy’s Prohibited Items Policy prohibits the sale of hazardous materials, including ingestible products that contain toxic, hazardous, restricted, or otherwise illegal ingredients. We reserve the right to remove listings that may violate the law or Etsy’s policies.
Are there limits on the type of health or medical claims I can make for my product?
Yes. As a general rule, you may not make claims that your dietary supplement product can diagnose, cure, mitigate, prevent, or treat a disease or medical condition. Please see our House Rules page on this topic for more information.
The FDA does allow some health and structure/function claims. The FDA may require specific disclaimers or pre-notification for such claims. Additionally, the FDA imposes other restrictions on the types of claims you may make regarding your dietary supplements or their ingredients. For more information on these restrictions and requirements please see FDA guidance here. We reserve the right to remove listings that may violate any legal requirement, including these requirements relating to claims.
Are there any good manufacturing practices that apply to me if I manufacture, process, label, or hold dietary supplements or other ingestible products?
Yes. It is your responsibility to establish and follow current good manufacturing practice set forth in FDA regulations. Please review the FDA’s guidance on current good manufacturing practices (CGMPs) for small entities for more information. Sellers should consult legal counsel to ensure compliance with CGMPs. We reserve the right to remove listings that may not have been manufactured, processed, packaged, stored, or transported in compliance with these practices, or that may be unsafe for any other reason.
Are there any reporting requirements that apply to me if I learn about an adverse event relating to a dietary supplement I sold?
Yes. If you become aware of someone having a serious health reaction or illness relating to your dietary supplement, you may have an obligation to report this adverse event to the FDA. For more information on reporting adverse events, please see FDA guidance here. The FDA’s safety reporting portal can be found here.
Words by Etsy Staff
