Dietary supplement companies often come to us unsure of how the U.S. Food and Drug Administration (FDA) regulates their products. The requirements are not immediately clear, especially when label claims and terms such as “nutraceuticals” or “functional foods” (not recognized by FDA) can blur the distinction between supplement and drug. In fact, FDA regulations for dietary supplements mirror those for food and beverages, but with some significant differences. Below lists some of the key requirements supplement companies should follow to ensure FDA compliance.
Facilities that manufacture, pack, or hold dietary supplements for U.S. consumption must register with FDA. Facilities located outside of the United States must designate a U.S. Agent for FDA communications at the time of registration.
FDA requires supplement facilities to renew their registrations between October 1 and December 31 of each even-numbered year, regardless of when they initially registered. For example, if a facility registers with FDA in September 2018, it will still need to renew its registration between October 1 and December 31, 2018.
Like conventional foods and beverages, dietary supplements require nutrition labeling, but with different content and formatting. “Supplement Facts” charts identify only those nutrients that are present, as well as any additional “dietary ingredients” such as herbs, botanicals, and amino acids. In 2016, FDA introduced new labeling requirements for supplements. Among other aspects, the new rules require:
- Vitamin D and potassium to be listed on the label
- A declaration for “Added Sugars”
- Revised units of measure for vitamins A, D, and E
- A footnote on products intended for children aged 1-3 stating “Percent Daily Values are based on a 1,000 calorie diet.”
As of this publication, FDA has proposed a deadline of January 1, 2020 for dietary supplement businesses grossing ten million dollars or more in annual sales to comply with new label rules. Small businesses are provided an additional year.
Supplement labels and advertisements are not permitted to bear claims that suggest they “treat, diagnose, prevent, or cure disease.” Such claims may result in FDA classifying them as drugs, which may require FDA approval and have stricter labeling requirements. Products shipped with these claims risk being charged as “unapproved new drugs” and subsequently detained. FDA’s regulatory procedures manual does not permit an “unapproved drug” to be relabeled or reconditioned in port, forcing the shipper to re-export or destroy the product.
Current Good Manufacturing Practices (CGMPs)
As part of the Dietary Supplement CGMP Rule, FDA requires supplement manufacturers to follow specific procedures and record-keeping to ensure safe production. Manufacturers must prepare and follow several process controls, including written master manufacturing records (MMRs) for each unique formulation and batch size of supplements. In order to ensure each batch meets uniform specifications, FDA requires MMRs to outline aspects such as:
- Identifying information for the supplement, including properties such as concentration or strength of each ingredient for each batch size
- Specifications for points in the manufacturing process that require controls to ensure quality of the supplement
- Specific actions needed to implement and verify these controls
- Corrective actions for when specifications are not met
Facilities exporting supplements to the U.S. must file prior notice of each shipment with FDA before it enters the country. The submission timeline for prior notice is dependent upon the shipment’s method of transit.
For more information about FDA dietary supplement regulations, register for Registrar Corp’s free webinar (to take place on April 19) for a comprehensive overview on how to comply. The webinar will conclude with a live question and answer session.
Don’t want to navigate the requirements on your own? Registrar Corp makes FDA compliance quick and easy. We can register your facility with FDA, serve as your U.S. Agent, review your supplement’s labeling and MMRs for compliance, and more. Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.