Deficient product notice

A test of wills is going on between the Food and Drug Administration (FDA), on the one hand, and the manufacturers, distributors and advertisers of food and dietary supplements, on the other.

At the center of the dispute is DOH-FDA Administrative Order No. 2011-0008 of the Department of Health, issued by then Health Secretary Esperanza Cabral in March 2010, ordering the removal of the phrase “no approved therapeutic claim” from all advertisements, promotional and sponsorship activities and materials of those products.

In lieu of that phrase, the following message was ordered posted: Mahalagang Paalala: Ang (name of product) ay hindi gamot at hindi dapat gamiting panggamot sa anumang uri ng sakit.

The same message is required to be clearly and audibly voiced over in audio advertisements or promotions, without being cut off, in the last line regardless of their duration.

The changes are aimed at “promoting and protecting the consumers’ health and welfare and fostering their right to proper information and education to facilitate sound choice.”

Injunction

Anticipating the adverse effects of the order on their sales, the manufacturers of food and dietary supplements requested DOH to replace the prescribed message with the phrase “Mahalagang Paalala (Name of Product) ay Hindi Gamot.”

They said the phrase “would be more consistent with the registration of food supplements which is basically based on its supplementary or established health benefits.” They claimed they will suffer irreparable damage if the order is strictly enforced.

Unable to get their way, the manufacturers filed suit in 2010 with a Manila regional trial court and were able to secure an injunction to suspend the implementation of the order.

Upon DOH’s petition, the Court of Appeals, in November 2014, dismissed the complaint and lifted the injunction.

It said the order “was issued as a valid exercise of the police power of the State for the prevention and protection of the general public who has the right to be informed of the nature and established curative effects of food supplements they buy.

“The purpose of the AO is to educate consumers that food supplements are not medicines that can cure illness and that food supplements are substitute for prescribed medicines.”

Resistance

Despite the dismissal of their complaint, however, the manufacturers have refused to comply with the message requirement, prompting the DOH to issue early this month another circular requiring compliance with its 2010 order.

The refusal does not come as a surprise. Expect the producers and distributors of food and dietary supplements, the majority of which are franchisees or agents of multinational companies, to fight the order all the way to the Supreme Court.

The resistance will be no different from the way local and foreign pharmaceutical companies tried to derail the enactment and implementation of the Generics Act of 1988 and Cheaper Medicines Act of 2008.

These laws seek to promote the production, distribution and acceptance of medicines identified by their generic names, and make vital medicine products more affordable to the public.

With the use of slick (read: deceptive) advertisements and advertorials, the oppositors of the laws tried to cast aspersions on the quality of generic medicines as against their branded counterpart, and even questioned the government’s right to regulate the manner by which physicians prescribe medicine to their patients.

Mercifully, after a couple of years, the two laws survived all the legal and political obstacles thrown their way by vested interests in the drug industry and medical profession.

Understanding

The food and dietary supplements industry has annual sales revenues of approximately P100 billion.

Considering this revenue intake, it would be foolhardy to think that manufacturers and distributors of these products will agree to submit without a fight to regulatory measures that could, directly or indirectly, decrease their profit margin.

By their refusal to comply with the DOH order, they are, in effect, admitting they have not been honest and truthful to the public about the true nature of their products.

To the ordinary Filipino, the phrase “no approved therapeutic claim” is hardly comprehensible, much less easy to pronounce. Try asking the sales personnel of drug stores what it means and you will either get a blank stare or an incoherent response.

The wording required by the DOH order is clear and crisp. Only the illiterate will be unable to understand its meaning.

In fact, although Filipino is widely spoken in the country, it would even be more effective it if were translated to the major dialects.

If, despite the warning message people continue to treat food and dietary supplements as medicines that can accomplish their advertised virtues, that’s fine.  Having been advised orally or in writing about the nature of the product they are buying, they cannot later turn around and blame the government if the touted health benefits do not happen, or, worse, result to serious complications.

By ignoring the warning, they are deemed to have willingly taken on the risk of using those products.

The bottom line of the opposition to the Generics Act of 1998 and Cheaper Medicines Act of 2008 is money.

The same holds true for the continued refusal to comply with the DOH order on labeling of food and dietary supplements.

Profit with honor is the mantra of socially responsible companies. Apparently, for some companies, that’s just a slogan.

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