Introduction:
The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers issues such as Supplement Facts Panel (SFP) labeling, ingredient labeling, and health claims.
In the USA, there are strict requirements for supplement labels. The FDA (Food and Drug Administration) requires all supplement labels to list the following: • Supplement name • Net quantity of contents • Direction for use • Warning statements if any • Supplement Facts Table • List of ingredients. All of this information must be displayed clearly and concisely.
You must comply with all the requirements if you want to do business in the USA, otherwise, the FDA may issue you a Warning Letter.
If you are unsure how to comply with these requirements, you can always consult a professional consultancy service, such as Quality Smart Solutions.
What is a dietary supplement?
A dietary supplement is a product that contains nutrients derived from food sources that are intended to supplement the diet. The most common type of dietary supplement is a vitamin or mineral supplement, which can be used to treat deficiencies or prevent health problems. Other types of dietary supplements include protein supplements, omega-3 fatty acid supplements, and herbal supplements.
Dietary supplements may be found in many forms, such as pills, tablets, capsules, gummies, soft gels, liquids, and powders. They can also be in the same form as a conventional food category, such as teas or bars, but only if the product is not represented as a conventional food or as a “sole item of a meal or the diet.” To be a dietary supplement, a product must also be labeled as a dietary supplement; that is, the product label must include the term “dietary supplement” or equivalent (e.g., “iron supplement” or “herbal supplement”).
Dietary supplements are not meant to replace food or medicine. They should be used as part of a healthy lifestyle.
What are the labeling requirements for dietary supplements?
In order for a dietary supplement to be sold in the USA, it must comply with the FDA’s labeling requirements. These requirements are designed to ensure that consumers can make informed decisions about the supplements they purchase and to protect them from products that may be harmful.
Dietary supplements in the USA must be properly labeled according to the FDA’s requirements. The label must include the supplement’s name, net quantity of contents, list of ingredients, and the manufacturer’s or distributor’s name and address.
Additionally, the label must state any warnings or precautions associated with the supplement.
Need help with your dietary supplement labeling?
What information must be included on the supplement label?
All dietary supplements must be labeled with the following information:
- The product’s name/identity and contact information for the manufacturer or distributor
- The term “dietary supplement” or equivalent on the principal display panel
- A list of all ingredients
- The recommended dosage
- Net quantity of contents
- Nutrition labeling/Supplement Facts Panel
- Any warnings or precautions associated with the product
- The expiration date or “best before” date
Who is responsible for ensuring that dietary supplements are labeled correctly?
It is the responsibility of the supplement manufacturer to ensure that their products are properly labeled by American law. The Dietary Supplement Health and Education Act of 1994 (the DSHEA) defines what a “dietary supplement” is, and includes specific labeling requirements for dietary supplements, as well as optional labeling statements.
The FDA recommends that consumers consult a healthcare professional before taking any dietary supplements, especially if they have pre-existing health conditions.
What do I need to do before selling dietary supplements in Canada?
- You need to obtain a Natural Product Number (NPN). This is a license issued by Health Canada for Dietary Supplements. The process to obtain a license can take 10 to 210 days depending on the ingredients in the formula. There is currently a pilot program which is trying to ensure that 95% of applications receive a license in 30 days. This program concludes at the end of February and initiatives, technology and processes will be improved to hit this target.
- You must have a compliant label, both in terms of content and layout as well as a bilingual label that is in both English and French.
- Your manufacturing facility has to be annexed to a Natural Health Product site licensed importer (these licenses are only issued to Canadian businesses). Often distributors hold an import site license but it is not necessary or a requirement that the distributor also be your importer on record. Depending on your needs and strategy for Canada, it may be preferable to work with a third party importer that is separate from the distributor.
Supplement Facts Panel (SFP):
The nutrition label for a dietary supplement is called a “Supplement Facts” panel. The major differences between the “Supplement Facts” panel and the “Nutrition Facts” panel are as follows:
- You must list dietary ingredients without Recommended Daily Intake (RDIs) or Daily Reference Values (DRVs) in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
- You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
- You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
- You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
- You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.
You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement.
What are the penalties for mislabeling dietary supplements?
The penalties for mislabeling dietary supplements in the USA can be severe. The FDA generally issues warning letters if companies are illegally marketing dietary supplements. If the warning letter is not addressed or acknowledged, more severe compliance and enforcement steps can be taken.
Prohibited Health Claims:
There are a few prohibited health claims that you cannot make when labeling your dietary supplement products in the USA. These claims are:
- Claims that the product can cure, treat, or prevent any disease
- Claims that the product can have an immediate or dramatic effect on the structure or function of the body
- Claims that the product is completely safe and has no side effects
In addition, all health claims made on dietary supplement labels must be supported by scientific evidence. It means that you will need to do your research and have studies to back up any claims you make about your product.
Conclusion:
In conclusion, the FDA dietary supplement labeling regulations are very important to follow. They help ensure that your dietary supplement is safe for use.
The FDA’s dietary supplement labeling guide provides clear and concise requirements for supplement labels in the USA.
These requirements ensure that consumers can easily understand the key information about a supplement, including its benefits, risks, and how to use it safely.
By following these guidelines, manufacturers can provide consumers with the information they need to make informed decisions about their health and well-being.
How can Quality Smart Solutions serve you?
Looking for regulatory assistance for your FDA dietary supplements? We can assist you with your; dietary supplement label review, supplement facts panel creation, Health Claims Substantiation Dossier, structure-function claims pre-market notification, facility registration and renewal, Prior Notice FDA Clearance, Foreign Facility U.S. Agent Service, NDIN, and more.
