FDA, DOH warn public vs unauthorized glutathione use

The Food and Drug Administration (FDA) said it only approves glutathione products with indications related to the treatment of "cisplatin chemotherapy" in response to concerns regarding a reported fatality associated with the use of glutathione.

“Other than that, kung ang produkto na ina-apply sa FDA ay hindi related sa treatment ng Cisplatin chemotheraphy ay hindi namin inaaprubahan ito (If the product being submitted to the FDA is not related to the treatment of Cisplatin chemotherapy, we do not approve it),” FDA Attorney III Pamela Angeline Sevilla said during a Teleradyo Serbisyo interview on Thursday, Jan. 18.

She also revealed that, as early as 2019, the FDA had issued public statements against unregistered glutathione products.

Meanwhile, despite the widespread use of glutathione, especially on social media, Sevilla cautioned that these products may not be FDA-approved.

"Two things could have happened: first, it may not have applied for or undergone the FDA authorization process, and second, the establishment might have applied for FDA authorization but did not meet the agency's standards,” she said in Filipino.

Sevilla also acknowledged the prevalent use of glutathione and assured that the FDA actively monitors such situations.

“We have not been remiss in warning the public about these unregistered glutathione products,” she said.

In addition, the FDA emphasized its regulatory activities and its cooperation with law enforcement organizations like the Philippine National Police (PNP), National Bureau of Investigation (NBI), and Criminal Investigation and Detection Group (CIDG) in response to concerns about the reported deaths linked to the use of a glutathione product.

Sevilla also mentioned the FDA's verification portal, which enables the general public to verify a product's registration status.

She advised consumers to use caution when it comes to medications, food, cosmetics, and devices, and to thoroughly inspect them before using them.

"Make sure that it undergoes the FDA process to ensure that each product we use is safe, effective, and of high quality," she said.

DOH warns vs ‘unsafe’ skin treatments 

Moreover, Department of Health (DOH) Secretary Teodoro Herbosa said during the Kapihan sa Manila Hotel forum on Jan. 17, that IV glutathione, despite its skin-whitening effects, poses serious health risks, including potential “kidney damage” and even “fatal” consequences.

"Glutathione, yes, it will whiten your skin, but it can damage your kidneys and kill you," he warned.

Addressing the issue, the Health chief stressed the importance of “health education” as a key component in combating the misuse of such treatments.

"I agree with regulations; using enforcement is one of them, but more importantly, education,” he added.

Herbosa clarified that IV glutathione is designed for hospital use.

“It is a rescue medicine for complications of cancer chemotherapy, and they found that cancer patients who are injected with it become fairer, prompting some doctors to start using it,” he said.

Its use outside of a hospital setting is considered “illegal” and akin to dangerous drug usage, he added.
 
He said there are ongoing investigations into the issue and instructed regional offices to thoroughly examine the clinic in question.

Furthermore, in the matter of the woman's death, Herbosa expressed uncertainty about whether it was solely due to IV glutathione, as reports indicated she had also undergone “stem cell therapy.”

"Licensed ba sila to use stem cells? Mayroon kaming listahan ng mga clinic na accredited and licensed by the DOH to give stem cells at 'yun yung chinecheck naming (Are they licensed to use stem cells? We have a list of clinics accredited and licensed by the DOH to provide stem cells, and that's what we are checking)," he stated, highlighting the importance of verifying clinic protocols, machine quality, and sterility standards.

Herbosa also said that the DOH would release further information as the investigation progressed, emphasizing the need to address clinics engaging in unsafe practices and underscoring the importance of client safety in stem cell therapy.

"Ang rinig ko dito sa mga facilities na sinasabi ay 'yung kumakalikot sa mukha ay hindi manlang doktor, 'yun problema 'yun at dapat ipasara ito (What I hear about the facilities being mentioned is that those meddling with the face aren't even doctors; that's the problem, and it should be shut down)," he said, expressing concern about non-medical personnel administering such procedures.

Herbosa further highlighted that claims of stem cells being safe due to their self-origin should be approached with caution.

He explained that once extracted, processed, and reintroduced into the body, there is a potential risk of infection.

“This is why DOH conducts checks to ensure that facilities adhere to sterility standards and other necessary protocols,” he said.