Compliant Labeling of Dietary Supplements - 6 Best Practices Manufacturers Should Follow

    The dietary supplement market has witnessed huge growth in the last decade and this boom in sales been accompanied by increased regulatory scrutiny. Both the government and federal agencies are concerned about the dangers posed to public health by misleading claims and labels on these products. The FDA is cracking down on the health claims being put forward by dietary supplement makers about their products. The agency is planning to widen its surveillance of the market to detect such claims. This article details how dietary supplements are currently regulated and six labeling best practices that dietary supplement manufacturer should follow in order to ensure compliance.

    What is a Dietary Supplement?

    A dietary supplement is essentially a product meant for ingestion that contains one or more dietary ingredients (in the form of a vitamin, mineral, herb, an amino acid, a dietary substance or other botanical). It is intended to provide nutritional value to a person's diet. Supplements cannot be represented or misinterpreted for use as a conventional food or make claims that they can cure/prevent diseases. They can be made available in various ingestible forms such as tablets, capsules, liquid, powder, soft gel and so on.

    Dietary supplements are designed to enhance the well-being, structure or function of the body through the supply of essential nutrients. They are not as strictly regulated as drugs in terms of safety and effectiveness (as no pre-market clinical testing is required in most cases).

    How are Dietary Supplements Regulated in the US?

    The FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations. 'Dietary Supplement' Regulations in the U.S are based on DSHEA, the Dietary Supplement Health and Education Act of 1994. The main centre concerned with or which has jurisdiction over dietary supplements is CFSAN, Centre for Food Safety and Applied Nutrition. Companies that manufacture, package or label dietary supplements should follow the Dietary Supplement Current Good Manufacturing Practices (cGMP) for quality control.

    The regulatory process has become more complex over the years, so as to address aspects of categorization of conventional foods, food additives and supplements:

    • Dietary supplements are codified under CFR 21: Food and Drugs with food labeling as CFR 101 and require no pre-market approval process, product formulation standards, product registration or facility registration.
    • Manufacturers are completely deemed responsible for all the claims (jointly enforced by both the FDA and the Federal Trade Commission) on their product.
    • The FDA expects that claims made by the manufacturer are truthful and not misleading (expressed and implied as per the statement made on the product, submitted with quality evidence).
    • The supplements should have a mandatory disclaimer along with a notification within the first marketing of the product.

    Specific guidance for dietary supplements (also detailing safety provisions, good manufacturing practices, nutritional support statements or claims, labeling aspects, exemptions if any) was developed by the FDA. Products or ingredients solely used in the manufacture of dietary supplements (not meant for commercial distribution) and low volume products etc. are exempt from labeling.

    6 Best Practices to Ensure Compliant Labeling of Dietary Supplements

    Labeling requirements are detailed and vary depending on the ingredients used in dietary supplements. Listed below are best practices to be followed for the compliant labeling of supplements.

    1. Ensure the Principal Display Panel is Complete and Readable
    2. The Principal Display Panel of the label is the most visible part of the supplement container. The Principal Display Panel:

      • must provide statements for the product,
      • should be spacious enough to include all the mandatory information
      • should contain clear information (must not appear crowded) with specified dimension requirements
      • must also contain required information on Alternate Principal Display Panels (if any)

      It is the main panel on the supplement package. Label statements that are required on the Principal Display Panel are the Statement of Identity and the Net quantity of Contents statement.

    3. Provide all required data in the Information Panel

      • The Information Panel should contain label statements like "Supplement Facts" panel and the Ingredient List.
      • It should also include details like name and place of business of the manufacturer, packer, or distributer (in case this information was not included in the main panel or Principal Display Panel).
      • It should be placed to the right (or as any adjacent panel in case - top is Principal Display Panel,) of the Principal Display Panel with only required information (without other intervening material).

    4. Ensure that Statement of Identity is Included in Label Statements
    5. The Statement of Identity is one of the most important features of the Principal Display Panel (or on Alternate Principal Display Panels, if present) and it should:

      • include name of the dietary supplement,
      • must be placed in lines parallel to the base of the supplement package
      • be included as one label statement (the word "Supplement" should be included in the statement) on the Principal Display Panel, preferably on the more visible side
      • incorporate a description of the product
      • display information in bold type with a suitable font size so as to magnify prominent printed matter on the front panel of label

      According to Federal regulations, the Statement of Identity for a dietary supplement is its descriptive term and can include the type of dietary ingredient(s) in the supplement product. A supplement can be identified by use of the term "dietary supplement" as part of the Statement of Identity.

    6. Provide Net Quantity of Contents on the Supplement Label
    7. Net Quantity of Contents on the Supplement Label (of the Principal Display Panel and on Alternate Display Panels, if any) is used to provide only the amount of dietary supplements in the package and not the weight of the container, packing materials and so on. There are some exceptions to this rule, for example when supplements are packed in containers and are to be delivered under specified conditions.

      This section should be:

      • located as a separate bottom section;
      • set apart from all other text in specified font requirements (information should be easy to read, be contrasting with the background color and displayed clearly)on the product label;
      • parallel with the base of the container

      The quantity of contents should be expressed in either:

      • weight, measure, numerical count or
      • a combination of numerical count/ weight or measure and

      The quantity of contents should be in specified units of both metric and as well as U.S. Customary System.

    8. Make sure the Nutrition Label has All Relevant Information
    9. The Nutrition Label for a dietary supplement is designated as "Supplement Facts" panel- and is included in the Information Label.

      • It includes the source list of dietary ingredients used in dietary supplements. Information on the Nutrition Label should be conspicuous, readable (text should be in uniform style either in upper or lower case) with required font and spacing between lines.
      • It should always contain 3 main pieces of information (Supplement Facts Panel, Ingredients list, name & place of business of manufacturer/distributor).
      • The source list of dietary ingredients with recommended % Daily Values should to be listed in a specified order in a column display with detailed information separating them from other dietary ingredients.

    10. Include FDA Mandatory Disclaimer information
    11. A mandatory disclaimer statement is required on the product label of any supplement bearing structure/function statement required by the FDC Act.

      • This information is mandatory on every single supplement package (must appear on each panel where a statement is made in bold font and must be enclosed in a box)
      • It should be located adjacent to each statement without any intervening material or combined with any other statements.

      Manufacturers who wish to display one claim on their package label need to put this disclaimer statement:

      "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

      In case of multiple statements / claims, a plural of the same statement can be listed.

      "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or mitigate any disease."

    Dietary Supplement Manufacturers Must Ensure Labels and Claims Comply with Federal Regulations

    Manufacturers must stay in compliance to applicable regulations and follow best practices outlined above, as consequences of non-compliance can result in penalties, citations or product seizures.

    Dietary supplement companies should take prompt action to correct the violations cited (within assigned timelines) and shoulder the responsibility to assure that all requirements of federal law and FDA regulations are met. They should also inform the FDA about corrective action taken to prevent the recurrence of any regulatory violations.

    How can dietary supplements compliance training help?

    The areas highlighted above are just a small part of the wide range of practices and processes for dietary supplements compliance. Subjects such as this are multi-faceted and complex and can be better understood after attending a training course such as the ones offered by ComplianceOnline. Our courses are available as live webinars, training recordings and seminars. We also offer customized training courses developed in conjunction with organizations that wish to train large groups of their employees.

    We offer training in other areas of dietary supplement compliance such as advertising and promotion, cGMP and other FDA regulatory requirements.

    If you need customized training courses or specialist dietary supplements compliance consulting services, please contact us through email [email protected] or
    call us at this toll-free number: +1-888-717-2436