Alternative medicine practitioner sued for violation of FDA laws on sale of unregistered health products

October 22, 2018

AN alternative medicine practitioner was slapped with criminal charges for violation of Food and Drug Administration (FDA) laws on sale of unregistered health products to public.

Ret. Police  Allen B. Bantolo, officer-in-charge of the FDA-Regulatory Enforcement Unit, filed the criminal complaint against Dr. Agustin-Bunch at the Tarlac Provincial Prosecutor’s Office recently of violation of Sec. 11 (a) and (j) of Republic Act 3720, as amended by RA 9711 (or the FDA Act of 2009) for her involvement in the manufacture, sale or offering for sale of unregistered health products to the public.

It can be recalled that on August 8, 2018, the FDA rendered a decision in the administrative case filed against Dr. Agustin-Bunch by a group of medical practitioners, and imposed administrative penalties against her for her involvement in the manufacture, sale or offering for sale unregistered health products. She was imposed a P1.072 million fine, which was accompanied by the cancellation of her license to operate (LTO) as food manufacturer, and the padlocking of her facility. 

As early as 13 June 2017, FDA already issued advisories about the subject unregistered health products, and subsequently issued Summons with Preventive Measure Order (SPMO) against Dr. Agustin-Bunch. During the service of the said SPMO, FDA was able to seize P858,500 worth of unregistered health products -- with name brands of Dr. Farrah’s Boston C, Dr. Farrah Cyeton and Dr. Farrah Skeleton -- and gave a stern warning for her to cease and desist from selling or offering for sale the unregistered health products to the public.

“After the first notice, which we served last 27 July 2018, we conducted another test-buy and purchased items from Dr. Farrah Bunch medical facility and we confirmed that she did not comply with the FDA’s cease and desist order for her not to dispense, sell and offer for sale her unregistered health products,” Bantolo said.

On August 17, 2018, FDA-REU applied for and was issued a search warrant by Judge Magdalena Balderama of the Tarlac Regional Trial Court Branch 64. Assisted by elements from Tarlac PNP, and local barangay officials, the FDA-REU implemented the warrant and again seized P60,000 worth of unregistered health products inside the respondent’s facility.

Dr. Agustin-Bunch filed a motion for reconsideration on August 20, 2018, and prayed for the reopening of her facility. However, in its resolution dated October 2, 2018, FDA denied Dr. Agustin-Bunch’s motion for reconsideration for her apparent failure to show proof that the subject health products are duly registered with the FDA.

FDA Director General Nela Charade Puno explained that the FDA is not a barrier to local and foreign inventors and practioners (industry) of alternative medicine or treatment, and is in fact very supportive of them, so long as they comply with the laws, rules and regulations.

“We at the FDA have a mandate, and the agency is dedicated in making sure that their products -- alternative medicines/treatment -- abide by regulations and are duly registered. This is to assure the safety, quality and efficacy of these products,” she said.

Section 11 of RA 9711 provides that “if the offender is a manufacturer, importer or distributor of any (unregistered) health product, the penalty of at least five (5) years imprisonment but not more than ten (10) years and a fine of at least Five hundred thousand pesos but not more than P5 million pesos shall be imposed (underscoring supplied)”.

The same section of the FDA law also states that: “Provided further, that an additional fine of one percent (1%) of the economic value/cost of the violative product or violation, or One thousand pesos (P1,000.00), whichever is higher, shall be imposed for each day of continuing violation.”