FDA warns vs unregistered Vitabears supplements

CAUTION The Food and Drug Administration says these dietary supplements are among the three products that have not been registered with the agency. —photo from Vitabears

MANILA, Philippines — Are you a fan of gummy bear food supplements that have become a popular alternative to plain, boring vitamin pills and capsules? Check if they are registered with the Food and Drug Administration (FDA) first.

The FDA has warned all healthcare professionals and the general public not to purchase and consume three dietary supplements of a popular brand: Vitabears Flawless Glow, Vitabears Skin Vitamins and Vitabears Sleep Vitamins.

“The FDA verified through online monitoring or post-marketing surveillance that the above-mentioned food supplements [are] not registered and no corresponding Certificate of Product Registration (CPR) [has] been issued,” the FDA said in Advisory Nos. 2024-0759, 2024-0760 and 2027-061, all of which were issued on May 9.

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“Since [these] food supplements [have] not gone through the evaluation process of the FDA, the agency cannot [ensure their] quality and safety,” noted the advisories signed by Dr. Samuel Zacate, FDA director general.

Under Republic Act No. 9711, or the FDA Act of 2009, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, nonconsumer use, promotion, advertising or sponsorship of health products without the proper authorization, is prohibited.

Sold online

As of Monday afternoon, the three unregistered Vitabears products are still being sold in online marketplaces, and even advertised by so-called social media influencers with large online followings.

The products are being sold for P499 each, as advertised on Vitabears’ social media accounts. Distributors and resellers mark their prices up.

The FDA directed all law enforcement agencies and local government units to ensure that the products were not sold or made available in the market or in their areas of jurisdiction. It also urged the Bureau of Customs to restrain the entry of unregistered products into the country.

Reached out for comment, Vitabears Inc., which is based in Pasig City, said the FDA registration of their three products were “still pending.”

“Our previous application was denied because our previously engaged filer was not able to submit all the requirements, which we already have at the time,” it said in a message the Inquirer received on Tuesday.

The company said they had initiated a new application for registration, along with other certifications, including halal certification.

“Here in Vitabears Inc., we value foremost the wellness and safety of our consumers and we strive to comply with all laws and regulations pertaining to our business. Rest assured that the current concern is being attended to and we are trying our best to secure them the soonest possible time,” it added.

Two of its food supplements — Vitabears Fat Buster and Vitabears Detox Vitamins — have CPRs issued by the FDA in 2023 that will expire in 2025.

Based on its website, all Vitabears products are manufactured in South Korea, and “undergo extreme sanitation and formulation testing before the final product is released.”

According to Vitabears, its Flawless Glow product contains “a carefully crafted blend of D-Biotin, essential vitamins (A, C, D2, E, B6, B12), pantothenic acid, choline, iodine, zinc and inositol” to help get “radiant hair and strong nails.”

Its Skin Vitamins have “Marine Type I and Type III collagen peptides, [which promote] overall skin health, increased elasticity, and improved hydration.”

Meanwhile, its Sleep Vitamins have a “unique blend, including melatonin, L-Theanine, passionflower extract, and 5-HTP, [and are] designed to promote relaxation, reduce stress, and support [a] balanced mood for a refreshing and peaceful slumber.”