Are You Amazon Ready?

by | June 3, 2021

As we learn more about Amazon and its evolving dietary supplements quality policy, individual sellers appear to assume more responsibility. In the Amazon 2.0 policy, the company’s added the requirement for dietary supplement brands to comply with 21 CFR Part 117-GMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods.

Amazon pulled some of the requirements directly from the applicable U.S. food safety regulations. While others seem to be internal risk-based interpretations. Suppose we related Amazon to the U.S. Food and Drug Administration (FDA). In that case, the Food Safety Modernization Act (FSMA) and the seven foundational rules are also the most significant shift in food safety regulations in more than 70 years. We want to help companies be ready for both FDA inspections and Amazon.

There are 10 reasons why all dietary supplements companies need to be FSMA compliant to be Amazon ready:

  1. Exemptions: Dietary supplements as finished goods are exempt from two of the seven 117 subparts, including Subpart C – Food Good Manufacturing Practice (GMP) and Subpart G – Supply Chain Programs. On the flip side, e’re required to be compliant with the other five subparts.
  2. Subpart G: I believe the dietary supplements industry should also be compliant with Subpart G – Supply Chain Programs. In Subpart G, the FDA has identified the modernized responsibilities for vendor qualifications. In my opinion, these are much more stringent than those in the supplement GMPs. With the potential of a modernized DSHEA on the horizon, often referred to as 2.0, it might not hurt to start preparing now.
  3. Allergen management: We’re exempt from Subpart C – Food GMPs because we must comply with our own GMPs (21 CFR Part 111) and Serious Adverse Events Reporting. However, in addition to 111 GMPs, a dietary supplement company/brand also must be compliant with any areas in 117 GMPs above and beyond our own. One area where 117 is above and beyond 111 includes allergen management. DS companies must comply with allergen management and controls. For example, see 117.35, 117.40, 117.80, and 117.135.
  4. Supplier qualification: Before FSMA, but heavily emphasized in the Preventive Controls for Human Food rule, is supplier qualification (Subpart G). Supplement companies must evaluate their raw material suppliers for compliance with all applicable U.S. food regulations. Your raw material suppliers and dietary ingredient suppliers will likely need to comply with one or more of the FSMA rules, including Preventive Controls for Human Foods, Foreign Supplier Verification Programs (FSVP), Intentional Adulteration, Food Defense, Vulnerability Assessments, and potentially the Produce Safety Rule. Is your staff prepared to conduct this evaluation?
  5. Hazard analysis: Regulators require a written hazard analysis for all food products, including dietary ingredients and raw materials. If you identify a hazard as reasonably likely to occur , then you must implement and monitor a preventive control.
  6. Food Safety Plans: Teams should be qualified to evaluate written Hazard Analysis and Food Safety Plans based on the risk of each material and supplier. A Preventive Controls Qualified Individual (PCQI) must conduct this evaluation, while assuming nine other significant responsibilities.
  7. Process controls: There are four types of preventive controls, including process controls. Companies must validate process controls.
  8. Training: Dietary supplements companies must be ready for the 117 personnel (food safety) qualifications. Regulators likely will scrutinize training records during an inspection to determine if the company satisfied the personnel training requirements. Sellers must train production, supervisors, quality, and sanitation staff to meet the required elements found in 117.4.
  9. PCQI: A PCQI is required to manage your food safety system.
  10. A return to normal: The FDA is returning to standard operations in July (under the best-case scenario). When they return to routine procedures, FDA staff will have no travel restrictions and restricted access to facilities.

While responsible companies have always considered GMPs, FSMA has also thrown many new expectations our way. All FSMA compliance dates remain in effect. If you’re not fully FSMA trained, you’re out of compliance.

Click here to check out the full schedule of virtual training sessions UNPA will be hosting over the next several months.

Larisa Pavlick is the Vice President of Global Regulatory and Compliance at United Natural Products Alliance (UNPA).

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