Regulation of dietary supplements sought
Credit to Author: Tempo Desk| Date: Sun, 07 Jul 2019 07:11:35 +0000
Parañaque City 2nd district Rep. Joy Myra Tambunting is batting for the proper regulation of supplemental medicines and other related preparations in the market for the sake of consumer protection.
Tambunting filed House Bill (HB) 1038, which seeks to put in place adequate safeguards for the protection of consumers against aggressive and exaggerated therapeutic claims of unscrupulous manufacturers in the advertisements for their supplements.
She said that most manufacturers of supplements and other dietary preparations using “NO THERAPEUTIC CLAIM” on the packaging and promotion of their product rely on fine print and disclaimers.
“Thus, unqualified substitution is allowed and the law cannot hold the physician responsible for adverse consequences,” Tambunting noted.
The lady solon pointed out that therapeutic decisions reached by physicians are based on a complex body of medical information relevant to a specific patient.
“It is not denied that therapeutic failure or toxicity may result from improper substitution of a drug at the pharmacy counter,” said Tambunting in the explanatory of her bill.
Supplemental medicine, as defined under the bill, refers to supplemental medicines, dietary preparations, and other related supplements including herbal preparations.
The bill mandates the Department of Trade and Industry (DTI), Bureau of Food and Drugs (BFAD) and other related agencies to prescribe rules and regulations prohibiting deceptive public advertisement, including marketing strategy of drug manufacturers and advertisers.
Moreover, the DTI shall include 1) rules against deceptive public advertisement, including marketing activities and other exaggerated marketing strategies; 2) a definition of deceptive, abusive and exaggerated advertising and marketing of said supplemental medicines, dietary preparation and other related supplements including herbal preparations; and 3) a standard of protection in promoting the welfare of the consumers.
The BFAD for its part shall prescribe the rules on the 1) proper mandatory package labeling as a requirement that supplemental medicines, dietary preparations and other related supplements ,including herbal preparations must adhere to; and 2) compliance with the required mandatory testing and approval as to ensure drug safety and efficacy.
The DTI and BFAD shall ensure and monitor the safety, therapeutic and bioequivalence, and post-marketing of said supplemental medicines, dietary preparations and other related supplements including herbal preparations.
The proposal provides that any person adversely affected by any supplemental medicines, dietary preparations and other related supplements, including herbal preparation and manufacturers, or advertisers who shall violate any rule prescribed under the provisions of the Act may, within one year after the discovery of the violation, bring a civil action against a person who has engaged or is engaging in prohibited acts so stipulated.
Such action may be brought to enjoin private parties, manufacturer or advertisers, or enforce compliance with any rule under the Act to obtain damages or to obtain such further and other relief as the court may deem appropriate. (Ellson A. Quismorio)