Dietary Supplement Label Review

Knowing the applicable regulations and requirements is the first step in creating a compliant label. The FDA regulates supplement labels under several rules, including the Nutrition Labeling and Education Act (NLEA) of 1990, the Dietary Supplement Health and Education Act (DSHEA) of 1994, and most recently, updated guidance addressing New Dietary Ingredient warnings and statements. All these regulations provide specific guidance for how dietary supplement manufacturers must approach various components of their product labeling.

The FDA’s regulation concerning dietary supplement labels is covered under Title 21 of the Code of Federal Regulations (CFR). Specifically, Chapter 1, subchapter H “Food Labeling” regulates all aspects of food and dietary supplement labeling. This includes ingredient lists, label claims, warnings or caution statements, storage instructions and batch-specific nutrition information if applicable. All content published on labels must be truthful, not misleading and must comply with relevant FDA regulations.

We offer you a suite of Dietary Supplement Label Review and Consulting Services to audit your product label and ensure that it complies with all applicable FDA rules and regulations.

Requirements and Regulations For Dietary Supplement Labels

Required Information for Dietary Supplement Labels

Dietary supplement labels must include certain information including the product name, common/usual name or specific term identifying the dietary supplement on the principal display panel. This should then be followed by a list of active ingredients with amounts and daily value amounts, along with manufacturing info, standard of identity designation for food that has it and country of origin statement. Additionally, special labeling restrictions may apply depending on the type of supplement being sold (i.e. vitamins or protein supplements). Finally, if applicable allergen labeling is required in accordance with 21 CFR 101.22 (F).

Guidelines for Structuring Product Labels

It is also important to understand the guidelines for structuring product labels so that they are both compliant and customer-friendly. The most important aspect of this is making sure that all information is clear, legible and conspicuous – everything must be easy to find and read within a reasonable amount of time. This means that manufacturers should use the appropriate font styles, sizes, contrasts and other design elements to ensure the customer can quickly access key information about their dietary supplement product.

Tips on Making Labels Appealing to Customers

Make sure you make use of the creative design elements at your disposal to create product labels that are attractive and attractive to potential customers. Use bold and different font sizes, colors, images, and other design elements to draw attention to your brand and key pieces of information (such as active ingredients, directions for use and warning statements). Utilize contrast, visual hierarchy (to communicate a sequence of information) and visuals in the form of icons or symbols. People should be able to quickly scan the label for essential information.

Testing & Compliance Requirements for Dietary Supplements

Manufacturers of dietary supplement products should ensure their products are tested to adhere to FDA labeling regulations and meet all compliance requirements. Labels should accurately represent the product, by clearly declaring ingredients and statements, as well as alerting customers of any possible safety risks or side effects associated with consuming dietary supplements. All packaging labels should be user friendly and prominently display truthful print to avoid being misleading. Additionally, make sure all directives such as special storage procedures and/or expiration dates are properly indicated on the product labels.

Understand the Supplement Facts Panel information needed:

Supplement Facts Panels (SFPS) provide in-depth information about a dietary supplement’s nutrients and ingredients. The FDA requires that all dietary supplement labels, including the supplement facts panel, contain specific label elements, such as a nutrient list; serving size; number of servings per container; calories per serving; and percent daily values for required vitamins and minerals. Additionally, product packaging must include a statement disclosing “Supplement Facts” on the principal display panel of the package. These facts must be stated accurately and clearly so consumers can make informed purchasing decisions.

Research regulatory labeling compliance rules:

Before launching a new supplement product, carefully research all applicable regulatory labeling compliance rules and make sure your product meets them. The FDA sets forth extensive requirements for all dietary supplements, so it’s important to understand the necessary label elements set forth under the law before you move forward with product launch. Additionally you should check with other relevant agencies that may have additional labeling regulations, such as state governments and international organizations.

Understand the need for additional language for label disclaimers:

In order to be considered legally compliant, it’s important to remember that your product label must include accurate and appropriate disclaimers and usage guidelines as required by law. These may include claims such as “This product is not intended to diagnose, treat, cure or prevent any disease” and “Not recommended for use by pregnant or nursing women.” It is the responsibility of the manufacturer to ensure all necessary language is included on the product label.

Design an easy-to-read nutrition label design to maximize customer understanding of your product facts:

It’s important that manufacturers use user friendly labeling designs so people can quickly read and understand the contents of their supplement products. This involves including ingredients, dosage amounts, and serving sizes clearly on the labels. When designing a label, make sure to include accurate information regarding the number of servings per container, amount of calories per serving and any potential allergens in bold font. Additionally, it is important to list any inactive ingredients present in the supplement to ensure full transparency for consumers.

USA Dietary Supplement Labels Review

Importing or selling a dietary supplement in the US requires the product label to be compliant with applicable rules and regulations of the Food and Drug Administration (FDA).  The FDA has a specific set of rules for labelling and claims that are related to dietary supplements on marketing, packaging and websites. In case of a misleading or false claim on a label, FDA or other regulatory agencies may file warning letters.

Dietary Supplement Label Review Checklist

Packaging Requirements

Packaging must contain a statement of identity, net quantity of contents statement, nutrition labelling, ingredient list, name and place of business, packer, or distributor.

Supplement Facts Panel

This panel contains saturated fat, total calories, calories from fat, total fat, cholesterol, sodium, total carbohydrate, protein, dietary fibre, sugars, vitamin A, vitamin C, calcium if they are present in measurable amounts.

Warning Statement

FDA mandates warning statements associated with safety and special preventive measures that, if not followed, could make the product harmful.

Label Statements

It requires placing all required label statements on the front label panel or on the information panel unless otherwise specified by the regulation.

Ingredient List

You need to place the ingredient list on dietary supplements immediately below the Supplement Facts Panel (SFP). If there is a lack of space below the SFP, place it immediately adjacent and to the right of the SFP.

Units of Measurement

Using proper units of measurement is obligatory. For instance, use milligrams (mg), micrograms (mcg) or other appropriate.

Dietary Supplement Label

Dietary Supplement Label Review Done By Our Experts

Our Dietary Supplement professionals conduct an in-depth, fast and effective dietary supplement label review. We will assist you by detecting mistakes or enforcement risks and help you correct them before you shop or print your products.

  • Ensure that dietary supplement labels are in adherence with FDA’s laws and regulations
  • Include all required ingredient labelling
  • Check whether you cater to the design and layout restrictions
  • Guide you of any non-compliant claims on your product
  • Inform you about color additive rules
  • Be sure whether you’re in compliance with certification requirements

Overview of FDA Regulations

Dietary supplements are held to a higher standard when it comes to label requirements. Manufacturers must provide clear, concise information about their products in order for customers to make an informed decision. Understanding the regulations set up by the FDA and other agencies will help you make sure your supplement labels meet all current requirements.

The Food and Drug Administration (FDA) is responsible for the regulations governing the labeling of dietary supplements. Labels must be complete, accurate, and not misleading. All labels must include a Supplement Facts Panel, which lists ingredients, servings per container, serving size, and percentage of daily value for key nutrients. Statements regarding dosage directions or health-related claims must also meet FDA guidelines when present on the label.

Health Canada assigns DINs, and the federal department responsible for regulating drugs and other health products in Canada assigns DINs. To obtain a DIN, a drug manufacturer must submit an application to Health Canada that includes detailed information about the drug product, including its composition, manufacturing process, and intended use. Health Canada reviews the application to ensure the drug meets all regulatory safety, efficacy, and quality requirements before assigning a DIN.
Dietary Supplement Label Requirements

Requirements for Product Identification

All dietary supplement labels must include the product name, the net weight of the contents, the name and address of the manufacturer, packer, or distributor, and a statement describing the place of business. Different countries have different regulations regarding required labeling, so it’s important to research local laws when deciding what information should be included on your dietary supplement labels.

Supplement Facts Panel

Dietary supplement labels must also include a ‘Supplement Facts’ panel, which describes the ingredients in the product. This panel must list each ingredient, as well as its respective quantity per serving (in metric weights), and any inert ingredients that are used to make up the remainder of the product. You should always strive to be accurate in your Supplement Facts panel, as incorrect information can lead to legal consequences or a recall of the product.

Dietary Supplement Label Requirements
Dietary Supplement Label Requirements

Statements & Warnings

Dietary supplement labels must also include any necessary statements and warnings. Statements must be included to indicate any known potential allergies or other potential adverse reactions that may occur when taking the product, such as if it contains wheat, soy, eggs, fish, shellfish or tree nuts. Warnings must also be included if the product contains any ingredient that needs special caution or has known side effects. These warnings are required by law and should always be included on your label.

Certified Organic Label Guidelines

If your dietary supplement has any organic ingredients, you may be able to list it as certified organic on the label. This allows consumers to know that the ingredient is grown and processed according to very strict guidelines, set out by the government. To qualify for an organic certification, all ingredients must have been grown without synthetic pesticides, antibiotics, or genetic engineering. Additionally, all processing must be done without irradiation or artificial preservatives or flavorings. When you include a certified organic label on your dietary supplement, you can help increase consumer trust and loyalty!

Dietary Supplement Label Requirements
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