GTE Attestation Deadline Draws Near – Are your Green Tea NHP’s Ready?

GTE Attestation Deadline Draws Near – Are your Green Tea NHP’s Ready?

October 9, 2018 By

Deadline for GTE Attestation: November 14, 2018

It has been almost a year since the safety review of green tea extract was released by Health Canada, and November 14 is the deadline for all GTE attestation amendments. All products on the market must comply with the newly updated Green Tea Extract Product Monograph. Here’s what it means for your green tea extract-containing natural health product (NHP).

You will have to confirm the amount of ECGC, green tea extract’s main antioxidant, to Health Canada, while incorporating the two new risk statements on your product labels:

  1. If you have a liver disorder, consult a healthcare practitioner prior to use. Stop use if you develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite and consult a healthcare practitioner.
  2. Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally).

 

Step 1: Complying with the GTE Product Monograph

The first step is to fill out the Health Canada Green Tea Extract Amendment Attestation Form. This form essentially informs Health Canada of your product’s ECGC levels while legally attesting to having fully compliant product labels on the market by the November 14th deadline, while allowing Health Canada to update your Product Licence Application (PLA) for you.

 

 

Why is There a New Green Tea Extract Monograph?

While the risk of liver-related injury was already included in the original green tea extract product monograph, new reports of serious liver injury both in Canada and internationally prompted Health Canada to undergo an updated safety review. It was determined that the current risk statements do not sufficiently support risk mitigation for green tea extract-containing products, with the new statements being implemented to ensure consumers are informed about this association.

 

 

Consequences of Missing the November 14 Deadline

Non-compliance could mean your product being pulled off the shelves, or even far more serious consequences. If your product with non-compliant labels remains on the market past November 14 and someone experiences one of the adverse events included in the new risk statement, the potential for damage to your brand and company greatly increases.

 

Beware that product labeling changes take time; it can take up to 8-12 weeks for your new labels to come to fruition and displace your old labels on store shelves. As the November 14th deadline looms, contact us at dicentra so that we can help ensure your product label is compliant, your EGCGs are quantified, your GTE attestation is submitted, and that all of your documents are in line moving forward.

 

dicentra’s qualified team is experienced in the preparation of all submission types, in all submission categories, including materials, extracts, enzymes, isolates, probiotics, and synthetics.

 

1-866-647-3279 | info@dicentra.com

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces.