Dietary Supplements

Your solution for meeting requirements of the Dietary Supplement and Non-Prescription Drug Consumer Protection Act

A Dietary Supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, botanical extracts fiber, fatty acids or amino acids that may be missing or may not be consumed in sufficient quantities in a person’s diet.

Regulatory Agencies Applicable Federal Laws
Food and Drug Administration (FDA) PLAW-109publ462.pdf
Health Canada-Marketed Health Products Directorate (MHPD) Food and Drug Act-Natural Health Products Regulations

Highlights – Rules & Regulations

Several important regulations applicable to the Nutritional and Dietary Supplement Industry are highlighted below:

Dietary Supplement and Nonprescription Drug Consumer Protection Act

  • Section 3: Adverse events meeting the FDA defined criteria for serious must be reported to the FDA within 15 days using the FDA Form 3500A and its accompanying data elements.
  • Although mandatory reporting is limited to serious adverse events, the manufacturer is obligated to document and assess every allegation of an adverse event associated with a dietary supplement to determine whether or not it meets the “serious” criteria for reporting to the FDA.
  • All records related to any adverse event report must be kept for no less than six years, regardless of whether the adverse event was reported to FDA. These records must be readily available for inspection by FDA compliance officers upon request.
  • Exemptions to the rules for small companies have expired.

Food and Drugs Act – Natural Health Products Regulations

  • Serious adverse reactions must be reported to Health Canada with 15 days.
  • Manufacturers must prepare Annual Summary Reports that include a critical analysis of the adverse event data reported for natural health products sold in Canada over a 12 month period.

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Your Industry Obligations

Dietary Supplement manufacturers should also be aware of the following compliance obligations:

    • Be wary of incorrect assumptions. Industry executives mistakenly assume that their products are inherently safe because dietary supplements are considered “natural” and do not contain “synthetic ingredients.”
    • Understand that consumers will most likely report adverse events directly to the manufacturer. This means that manufacturers need to implement additional processes for differentiating between those adverse effects which may represent a potential safety concern from those having nothing to do with the use of the product. Be aware of background noise involving adverse events not related to product use.

Dietary Supplement and Nonprescription Drug Consumer Protection Act

Guidance Documents Forms
Read more at fda.gov Read more at fda.gov

Food and Drug Act – Natural Health Products Regulations

Guidance Documents Forms
Read more at hc-sc.gc.ca Canadian-AE-Form.pdf


Principles of a Best Practice Dietary Supplement Post-Market Surveillance System

  • Ensure that pre-market assessments or beliefs of inherent safety are realized during consumer use of the product.
  • Ensure known safety concerns have been identified and considered, as well as stated on product warning labels.
  • Ensure the post-market surveillance system is sufficiently “sensitive,” such that potential threats or safety concerns would likely be included in the monitored events.
  • Ensure the system is sufficiently specific to allow detection, differentiation and ultimately determination of real vs. perceived threats.
  • Identify intended and unintended patterns of use which may potentially contribute to unintended effects.
  • Allow assessment of product performance by itself or in the presence of other products or substances.
  • Help ensure that effects in unique populations are considered when monitoring safety.
  • Further define, document and confirm a relative “safety profile” for the product during real life conditions of use.