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Dietary Supplements Regulations in the U.S


The U.S. FDA does not approve food, beverages, or dietary supplements. The Agency does not require a pre-market approval for any conventional food or dietary supplements. So, companies don't need to submit their product information, or labels to the FDA. They don't need an inspection before marketing their products. However, the FDA expects companies to comply with the rules and regulations in place. Companies that don't follow the rules and regulations will have to face FDA enforcements which include inspections, import refusals, import alerts, warning letters, suspension of registration, and/or civil and criminal penalties. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations.

    What Constitutes a Dietary Supplement?

    The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Examples include vitamins, minerals, amino acids, and herbs or botanicals, or other substances that can be used to supplement the diet.

    FDA Product Classification

    The FDA may classify a product based on its intended use. The most common product that the FDA oversees include conventional food or beverage, dietary supplement, drug, and cosmetic.

    Intended use can be determined from the claims made about the product in its labeling, advertising, promotional material, or any other appropriate elements. It can also be determined based on the ingredients used in the product.

    Conventional foods are those which are in the form in which they are traditionally consumed while dietary supplements are foods may take a different form. Examples of conventional foods include fruits, legumes, nuts, seeds, whole grains, seafoods etc. Dietary supplements come in many forms including tablets, capsules, powders, energy bars, and liquids.

    Product Compliance Requirements

    Registration of the Food Facility
    After the 9/11 events, the Congress passed the Bioterrorism Act of 2002. The Act directed FDA to promulgate regulation about registration of any facilities that manufacture, process, or pack food including beverages and dietary supplements. However, trading companies, personal residences, transportation only providers, farms, retail food establishments, fishing vessels and USDA-regulated facilities are exempted from the registration requirement.

    Renewal of the Registration
    Every two years, always on the even numbered years, companies must renew their registration. Failing to renew the registration may result in cancellation of the registration.

    Compliance Requirements for Non-U.S. Facilities

    Designation of a U.S. Agent
    Those facilities located outside of the U.S. must designate a U.S. Agent at the time of registration. It includes a verification where by the U.S agent accepts the designation. The agent is responsible for coordinating an FDA inspection, responding to FDA actions and communications promptly, and pay the FDA re-inspection fees.

    Prior Notice
    Companies located outside the U.S. must file a prior notice to FDA of every shipment they send to the U.S. The notice may be filed by the exporter, importer, or a third party. This notification is even required for samples. Failing to file the notice could lead to detention of the product in the port. The notice must include information about the facility and the shipment.

    Dietary Supplement Labeling Requirements

    The following are the minimum labeling requirements:

    Statement of Identity

    The statement must include the product name and identify itself as a dietary supplement. Although you may replace the term dietary with the type of ingredients that are in the product, having one of them on the product label is a mandatory requirement. The product must be labeled either as conventional foods and beverages or dietary supplement based on its actuals.

    Net Quantity of Contents

    The net quantity of content informs consumers of the amount of dietary supplement that is in the container or package. The net quantity of content must be located on the product label as a distinct item in the bottom 30 percent of the principal display panel in lines generally parallel to the base of the container. Learn more about dietary supplement guide on net quantity of contents here.

    Supplements Chart

    The supplement facts must contain the list of names and quantities of dietary ingredients present in the product's 'serving size' and 'servings per container'. Please note that there are differences between dietary facts charts and nutrition facts charts.

    Ingredients List

    The list of ingredients must be displayed in descending order of predominance by weight. If all source ingredients are listed in the supplement facts panel, and there are not other ingredients, such as excipients or fillers, an ingredient statement is not needed.

    Other Details

    Other details required include manufacturer, packer, or distributor name and address, and domestic U.S. mail address and phone number to which a consumer can report a serious adverse event. If an adverse event is reported, the company must notify the FDA.

    Understanding the Types of Dietary Supplement Claims

    Nutrient Content Claims
    Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite.

    Health Claims
    Health claims describe the risk reduction of a disease related to the consumption of a certain nutrient.

    Structure Function Claims
    Structure function claims describe the role or mechanism of a nutrient to affect the structure or function of the body. They may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function.

    Food Safety Regulations

    Title 21 Code of Federal Regulations, Part 111: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
    This regulation applies to manufacturers, packagers, labelers, or holders and includes importers as well.

    The manufacturing facilities of certain types of human food including dietary supplements are required to have a production and process control system in place. The design requirements for production and process control are stated in 21 CFR B' 111.60:

    1. 'Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and
    2. The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel.'

    21 CFR B' 111.205 specifies the requirement for establishing a master manufacturing record

    1. You must prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch.
    2. The master manufacturing record must:
      1. Identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and
      2. Establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications identified in accordance with paragraph (b)(1) of this section.
    3. You must make and keep master manufacturing records in accordance with subpart P of this part.

    21 CFR B' 111.260 specifies what needs to be included in the batch records

    1. The batch, lot, or control number:
      1. Of the finished batch of dietary supplement; and
      2. That you assign in accordance with B' 111.415(f) for the following:
        1. Each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement;
        2. Each lot of dietary supplement, from the finished batch of dietary supplement, that you distribute to another person for packaging or labeling;
    2. The identity of equipment and processing lines used in producing the batch
    3. The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained;
    4. The unique identifier that you assigned to each component (or, when applicable, to a product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used;
    5. The identity and weight or measure of each component used;
    6. A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;
    7. The actual results obtained during any monitoring operation;
    8. The results of any testing or examination performed during the batch production, or a cross-reference to such results;
    9. Documentation that the finished dietary supplement meets specifications established in accordance with B' 111.70(e) and (g);
    10. Documentation, at the time of performance, of the manufacture of the batch, including:
      1. The date on which each step of the master manufacturing record was performed; and
      2. The initials of the persons performing each step, including:
        1. The initials of the person responsible for weighing or measuring each component used in the batch;
        2. The initials of the person responsible for verifying the weight or measure of each component used in the batch;
        3. The initials of the person responsible for adding the component to the batch; and
        4. The initials of the person responsible for verifying the addition of components to the batch;
    11. Documentation, at the time of performance, of packaging and labeling operations, including:
      1. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels;
      2. An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record; and
      3. The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results;
    12. Documentation at the time of performance that quality control personnel:
      1. Reviewed the batch production record, including
        1. Review of any monitoring operation required under subpart E of this part; and
        2. Review of the results of any tests and examinations, including tests and examinations conducted on components, in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements;
      2. Approved or rejected any reprocessing or repackaging; and
      3. Approved and released, or rejected, the batch for distribution, including any reprocessed batch; and
      4. Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement.
    13. Documentation at the time of performance of any required material review and disposition decision.
    14. Documentation at the time of performance of any reprocessing.

    Resources

    • Dietary Supplement companies must ensure that any product claims they make are "truthful and not misleading" under FDA and FTC regulations. To meet these standards, the FTC has stated that claims must be substantiated by "competent and reliable scientific evidence." The course Strategies for Substantiating Dietary Supplement Claims will help: 1) identify claims; 2) characterize/rank claims; and 3) determine the level of scientific evidence needed to substantiate different types of claims.
    • The webinar 'Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates' will cover how dietary supplement companies should label their products for the US market per FDA requirements, considerations to avoid claims, building regulatory compliance into company programs for development and launch of properly labelled dietary supplements.
    • Experience and a clear understanding of the Dietary Supplement cGMP (DS cGMP) regulations are absolute necessities when building or maintaining an FDA compliant dietary supplement company. Having a good foundation in the regulations enables you to be confident in exactly what your responsibilities are in the eyes of the FDA and significantly improves your chances of achieving compliance in the most sustainable and cost-effective way possible. If this seems to be a daunting task and you're not sure where to start, you will certainly benefit from attending this webinar on the dietary supplement cGMPs. The webinar 'Simplifying the Dietary Supplement cGMPs for Those Confused by the Regulations' will explain cGMP regulations for dietary supplements.
    • For a full review the regulations that impact Dietary Supplements in the US, EU and Canada, attend this informative seminar. The seminar will discuss how to verify that products are compliant with these regulations. Differences with food and drug regulation in these countries will be noted as well. It will also cover what qualifies as a dietary supplement or dietary ingredient, how to ensure GMP compliance as well as detailed requirements for labeling and acceptable marketing claims. An update on current events within the Supplement industry and the potential impacts to Manufacturers and Distributors in the US, EU and Canada will also be presented and discussed.