FDA Announces FSMA Food Traceability Proposed Rule

On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record keeping requirements for certain foods.

Although existing FDA regulations already require that certain records are established and maintained, it only forms a baseline for traceability record keeping. These additional proposed requirements will not only allow for standardization of records throughout the industry but will also allow the FDA to more quickly identify a source of contaminated product, reduce the scope of recalls and conduct more timely root-cause investigations.

A list of foods that will be subject to the proposed requirements has also be drafted and can be found here, “Food Traceability List”. The requirements of this proposed rule would only apply to foods that are on the FTL, which includes foods that have the listed foods as ingredients. However, the FDA encourages the voluntary adoption of these practices for all foods.

Key Features

Critical Tracking Events (CTEs)

Growing, receiving, transforming, creating and shipping have been identified as CTEs where records with Key Data Elements will be required. These records will need to contain the traceability lot code of the foods relevant to these elements.

Traceability Program Records

Additionally, any persons who manufacture, process, pack or hold foods that are listed on the FTL will be required to maintain traceability program records.

  • A description of relevant reference records – This traceability program record must include a description of the reference record including where on the reference record the traceability information appears.
  • A list of foods on the FTL that are shipped – Anyone who ships food that is listed on the FTL is required to keep a list of which listed foods they ship. This includes the traceability product identifier and the traceability product description for each food.
  • A description of how traceability lot codes are assigned.
  • Other information needed to understand the data provided within the require records.

Additional Requirements

The proposed rule would also require that:

  • Records be maintained as either original paper records, electronic records, or true copies. They must also be legible and stored in a way that will prevent deterioration or loss.
  • Traceability records must be provided to the FDA no later than 24 hours after the request is made.
  • An electronic sortable spreadsheet containing all relevant traceability information must be provided to the FDA within 24 hours of a request when necessary to assist during an outbreak, recall or other threat to public health.

Full details can be found here


Regulatory Considerations for Non-Medical Masks or Face Coverings

Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings, and the circumstances under which such masks or face coverings would be subject to the regulatory requirements for medical devices during the COVID-19 pandemic.

Generally, non-medical masks or face coverings are made of fabric and come in various shapes, sizes and styles. They are typically sewn and secured with ties or straps around the head or behind the ears. They may be made in a factory, by a home-based small business or hand-made by people for self-use or donation to others. Such masks and face coverings may help reduce the spread of respiratory droplets from the user to others or to the surroundings.

In the context of the COVID-19 pandemic:

  • Masks or face coverings that make medical claims or representations to reduce the risk of or prevent the user from contracting COVID-19 are deemed medical masks. They are regulated as Class I medical devices and require medical device licensing.
  • Masks or face coverings that DO NOT make any medical claims, representations or indicate they will reduce or prevent the user from contracting a disease, do not require any type of licensing.

Examples of medical claims or representations include:

  • to protect the user from contracting COVID-19
  • for anti-viral or anti-bacterial protection (for example, contains a drug or biologic)
  • for use as a medical mask
  • to provide liquid barrier protection
  • designed as a respiratory protective device (for example, used for particulate filtration)
  • for use in high-risk aerosol generating medical procedures

Whereas examples of non-medical claims are:

  • Face coverings can play an important role in situations where physical distancing is not possible or is unpredictable.
  • When worn properly, a person wearing a non-medical mask or face covering may reduce the spread of their respiratory droplets.
  • These non-medical masks or face coverings have not been tested to meet any standards. Although encouraged, wearing a non-medical mask or face covering is not a substitute for physical distancing and hand washing.

All medical masks and face coverings (that make medical claims, as noted above) must meet specific international standards for Class I medical devices, such as ASTM F2100. These standards include requirements for bacterial filtration effectiveness, and may include specifications for particle filtration efficiency, flammability and fluid resistance. Furthermore, the labelling for medical masks must contain clear statements on their intended use and specific performance specifications for their proper use (for example, filtration efficiency and fluid resistance). Medical masks must come with bilingual labelling, either on the packaging or with the device itself.

Medical masks may be authorized for sale or import into Canada through the following routes:

  • interim order authorization to import and sell medical devices related to COVID-19
  • expedited review and issuance of Medical Device Establishment Licences related to COVID-19
  • exceptional importation and sale of certain non-compliant medical devices related to COVID-19

The regulatory pathways outlined above provide Canadians with information about the degree of protection they may expect from a medical vs. non-medical mask or face covering. This will allow them to select a product based on their individual risk profile. For example, people who are at risk of more severe disease if infected with COVID-19 may wish to use a mask with an established higher level of protection.

Companies importing masks/face coverings, medical or non-medical, may be requested by the Canada Border Services Agency (CBSA) to provide proof of a Medical Device Establishment Licence (MDEL). To ensure there are no hold ups at the border and that product is imported smoothly and in a timely fashion, our specialists recommend securing a MDEL for your business to be on the safe side.

As demand for medical devices, disinfectants and hand sanitizers continues to increase to keep the public safe, our team continues to work tirelessly to deliver the compliance and import solutions that are needed.  Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance needs during and after licensing!

Don't miss updates from Health Canada and FDA.

If you are looking for the latest regulatory updates or want the newest regulatory requirements guides, please leave your email and we'll keep you posted.

We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.