Local FDA flags sale of unregistered Australian-made ‘miracle balm’

October 27, 2021 - 3:03 PM
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Lucas' Papaw
Pictures of Lucas' Papaw 25 g ointment. (Photo from Facebook/Lucas' Papaw Philippines)

(Updated, Oct. 28; 12:21 p.m.) The local Food and Drug Administration flagged the sale and distribution of an Australian-made “miracle balm” that has been circulating in the Philippine market for years already.

FDA Philippines on its Advisory No. 2021-1158-A said that the Lucas’ Papaw Ointment in 25 grams has not been issued a Certificate of Product Registration (CPR).

A CPR is among the certifications that the regulatory agency requires from business operators and owners before their products are released in the local market.

The evaluation process for a CPR, according to the FDA, “entails checking of the safety and quality of a respective product with applicable standards and issuances.”

“Dahil dito, hindi masisiguro ng Ahensiya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan,” FDA’s advisory said.

It warned establishments and entities to refrain from distributing and selling the product until it has secured authorization.

Local government units and law enforcement agencies are also called to monitor their areas of jurisdiction for the potential sale and distribution of the product.

The Lucas’ Papaw ointment is an Australian-made product by the Lucas’ Papaw Remedies, a family-owned company that has been existing for over 100 years.

The company was named after the formulator of the ointment, Dr. T.P. Lucas, a medical practitioner and botanist who believed that papaw “was the finest natural medicine yet discovered.”

Its website says that the Lucas’ Papaw ointment is “ideal” to be applied on lips that have “inflamed, chapped or broken skin.”

It also “helps skin retain its own moisture which stops it from drying out.”

The topical application has supposed “healing properties” as well. It is also used for wound care, during instances of nappy rash, sports injuries, and mosquito bites and burns.

“It can be used as an aid for healing splinters and thorns, minor burns and scalds, sunburn, gravel rash, cuts and minor open wounds,” its website said.

The company also said that the ointment uses a “pharmaceutical grade petroleum jelly that is strictly certified to ensure its safety and quality.”

“USP grade Petrolatums are not mutagenic or toxic. Petroleum jelly is the ‘carrier’ that supports the active ingredient – fresh fermented papaw. Petroleum jelly does not block pores, is not carcinogenic or toxic,” it said.

“It has been affirmed to be non-comedogenic (does not block pores) and to not cause allergic reactions (American Academy of Dermatology Invitational on Comedogenicity, 1989),” the website added.

The company also said that the Lucas’ Papaw ointment is listed with the Therapeutic Goods Administration (TGA) of Australia.

“When a product is listed with the TGA, as Lucas’ Papaw Ointment is, the product must prove its effectiveness against any health claims made, and it must be audited against the Code of Good Manufacturing Practices. The TGA conducts audits on a regular basis to ensure safety and effectiveness of the product,” it said.

The product has been running a Facebook page in the Philippines since 2017.

The admin of the page, in response to the FDA advisory, told Interaksyon that they are “working on the FDA approval again” for the products to be sold both as a drug and cosmetics product.

According to them, the advisory said that the Lucas’ Papaw Ointment in 25 grams is not intended to be sold as a drug product.

“The FDA here in the Philippines didn’t accept the studies that were presented to them which was done in Australia, so our FDA Approval for our products is under the cosmetic category, which means we can sell it but it should be under cosmetics,” the page admin said.