They say that ‘The secret of enjoying a good wine is to first, open the bottle to allow it to breathe; if it does not look like it’s breathing, give it a mouth-to-mouth.’ But if you’re a businessman who wishes to import fine wines into the Philippines, you might want to give a thought first on the regulations surrounding the trading of such goods else, you might find your product listed in the Food and Drug Administration’s (FDA) ban page instead of being part of an industry that by 2021 is expected to reach 28 million liters in total volume sales. The Philippine FDA may seem to be a very strict regulatory unit but like any other government agencies, their ultimate goal is to protect the consumer by ensuring that only quality products flow into the domestic market.

Generally, grape wines and related produced not made from grapes are classified as Low-Risk Food Products but regardless of the risk classification, you as the importer or distributor should be able to provide documentary requirements with full disclosure on the technical formulation to prove the safety and quality of your wines, such as a Certificate of Analysis. Before 2014, it was verify difficult to register such products because FDA would require a new Certificate of Product Registration (CPR) for every wine vintage – that’s right, a Cabernet Sauvignon Caymus 2007 would be required for a new CPR even if you have already previously registered Cabernet Sauvignon Caymus 2006. In the past, this would often result to confusion, wasted resources and missed time-to-market opportunities for most businesses.

Fortunately, through FDA Circular 2014-022, distributors and importers with previous valid CPRs for wines may import a new batch with a different vintage, aroma, taste or alcohol content so long as the formulation is the same. Furthermore, instead of going through the entire re-registration process, the new circular now requires distributors and importers to just submit the following documents:

1) Notification letter from the company;
2) Notarized Affidavit of Undertaking that the changes on the label are only vintage year, aroma, taste, and/or alcohol content;
3) Label/s reflecting the only change on the label i.e., vintage and/or alcohol content

While it may seem complicated and time-consuming, our pharmaceutical division has developed a high-level of expertise when it comes to registering products with the FDA. We have a team of dedicated and seasoned Regulatory Unit who has helped ushered hundreds of importers and distributors to success. Why worry about the registration of your wine products when all you have to do is to provide us the needed documents and information, sit back, relax and wait for your CPR.

If you wish to import wines or any other category of products, our experienced FDA team will certainly help you.

For a complimentary initial consultation with our FDA registration experts, reach out to us through any of the convenient channels provided below:

• Contact Us Here
• Fill out the form below
• Call us at: +63 (02) 8540-9623
• Send an email to: info@tripleiconsulting.com

Let us handle the complexities of dealing with the FDA while you concentrate on achieving your primary objectives.