Is the alcohol you’re drinking registered with the FDA?
Is the alcohol you’re drinking registered with the FDA?
This is the extensive process a manufacturer must go through to apply for FDA approval

MANILA, Philippines – As the Philippines Food and Drug Administration (FDA) recalls samples of Cosmic Carabao gin, which they found to contain a high level of methanol, consumers have now been reminded of the importance of exercising caution especially, when it comes to things they ingest.

FDA officer-in-charge Dr. Eric Domingo said that Juan Brew, which manufactures Cosmic Carabao, is licensed to manufacture and distribute liquour. But Cosmic Carabao itself has no certificate of product registration.

According to the FDA’s Center for Food Regulation and Research (CFRR) electronic registation user manual, those seeking to secure a certificate of product registration must fill out an application form through FDA’s e-portal, which can be accessed through their website.

After logging in to the e-portal, they must fill out an application form, where they must specify the type of food product (low risk, medium risk, or high risk), the food categorization, the brand name, the product name, and the company name and address.

According to the manual, alcoholic beverages fall under the category of low risk food products.

These are products defined as “foods that are unlikely to contain pathogenic microorganisms and will not normally support their growth because of food characteristics; and foods that are unlikely to contain harmful chemicals.”

Depending on the product being registered, and whether the applicant is a manufacturer, importer, or distributor, they must also submit information such as complete addresses of suppliers or manufacturers, and attach various documents to their application, including licenses, certifications, and registration with GMP (Good Manufacturing Practice) compliance.

They also have to provide a complete list of the product’s ingredients in descending order of proportion.

Those who apply for a certificate must also submit a complete list of the product’s ingredients, as well as physical, chemical and microbiological specifications.

The product’s shelf life and packaging material type must also be specified.

Other documents that need to be attached include an image of the product label, as well as a picture of the product in commercial presentation, from various angles.

After supplying all the many details that the form requires, the applicant also has to pay a corresponding fee, which is based on the product type, and the number of years the certificate is being applied for. They must then submit a sample of the product in its commercial presentation to the FDA.

An initial application takes 114 calendar days, during which the FDA evaluates the documents, as well as the actual product.

The entire process of securing a certificate of product registration is meant to safeguard consumers. In a statement, the FDA warned the public to “exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals.” (READ: ‘Stay safe’: Netizens help warn public vs Cosmic Carabao Gin)

People can check whether a product has been registered with the FDA on their website. –

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