By Zsarlene B. Chua, Reporter

The case of the ‘no therapeutic claims’ disclaimer

Posted on August 15, 2014

ACCORDING to the latest data by the Food and Drug Administration (FDA), there are currently 2,588 registered food supplements in the Philippines, with each supplement hinting at least of the promise of a healthier body or claiming it can help treat such conditions as diabetes and arthritis, help a person lose weight or delay aging.

Yet each carton or bottle, each ad contains an often ignored statement:

“no approved therapeutic claims.”

This basically means the supplements are not yet proven to be an effective treatment to the conditions they promise to address.

So what are food supplements really, and what can they do for one’s body? Can they really live up to their suggested benefits?

Republic Act 9711, the law strengthening the regulatory capacity of the Bureau of Food and Drugs, has an amended definition of “food/dietary supplement,” as follows:

“Food/dietary supplement means a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb, or other botanical, amino acid, and dietary substance to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It usually is in the form of capsules, tablets, liquids, gels, powders or pills and not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines.”

The last sentence may be deemed the operative part of that definition.

Nutritionist Kathleen M. Zelman, in an article she wrote in 2011 for the health information company WebMD (where she serves as director), said the primary function of supplements is to fill in “small nutrient gaps.”

“They are ‘supplements’ intended to add to your diet, not take the place of real food or a healthy meal plan,” Ms. Zelman wrote in her article titled, “What Vitamins and Mineral Supplements Can and Can’t Do.”

Sought for comment, Adrian Paul J. Rabe of the Philippine Society for General Internal Medicine said: “Food supplements are prescribed for specific patients, including those who are undernourished or at risk of undernourishment.”

Dr. Rabe said he doesn’t prescribe supplements as a rule, and even discourages it when patients ask, “because they frequently waste money on these supplements than on their actual medications.” The number of food supplements out there in the market is a concern for him.

“They divert the resources of patients from medications that work, to these substances that aren’t proven to work,” Dr. Rabe said. “For some, they even give false hopes to patients with severe illnesses. Like snake oil salesmen, those who sell these supplements promise cures for cancer, end-stage kidney disease, and so many other illnesses. Truly, these claims are too good to be true.”

The reason precisely why food supplements carry the “no approved therapeutic claims” is they do not qualify as drugs or other medications.

Drugs have the backing research data and trials for their approval, Dr. Rabe said.

“A drug has a definite intended effect on the body, proven by a study,” he said. “A food supplement is literally an add-on to one’s oral intake.”

And yet, he notes, food supplements manage to circumvent the verification process applied to drugs by “not claiming any therapeutic effects when they apply at the FDA. All they have to prove is general safety using animal studies.”

Once approved, “many food supplements are marketed for therapeutic effects,” Dr. Rabe said. “Good examples include herbal supplements.”

Sought for comment, Maria Theresa C. Cerbolles of the Food and Drug Administration (FDA) cites a notice -- Bureau Circular 2007-002, titled, “Guidelines in the Use of Nutrition and Health Claims in Food” -- which acknowledges precisely how health products are being marketed.

Under that circular -- which cites Republic Act 7394 or the Consumer Act of the Philippines -- the Bureau of Food and Drugs is authorized “to enforce compulsory labeling and fair packaging to enable the consumer to obtain accurate information as to the nature, quality and quantity of the contents of consumer products and to facilitate comparison of the value of such products.”

“It is likewise declared therein that the State shall protect the consumer from misleading advertisements and fraudulent sales promotion practices,” the circular also said.

Ms. Cebolles, however, also cites certain approved drugs which began as food supplements.

“[A] vitamin preparation which was previously approved as food supplement and converted to a drug like Centrum. This had initial registration as food supplement [but is] currently registered as a drug under the generic name, ‘multivitamins and minerals,’” she said.

Otherwise, supplements need not to follow the strict authentication required for drugs, even if many of those products are, in the end, promoted as having greater health benefits.

This situation prompted health authorities in 2010 to endeavor revising the “no approved therapeutic claims” label. The Department of Health (DoH) Administrative Order 2010-0008 expressly prohibited the use of that label in all health products and required instead the Filipino translation, “Mahalagang paalala: Ang [name of product] ay hindi gamot at hindi dapat gamiting panggamot sa anumang uri ng sakit” (Important message: [name of product] is not a medicine and should not be used to treat any kind of ailment).

The Chamber of Herbal Industries of the Philippines, however, went to court to question that order and managed to secure an injunction.

Manila Regional Trial Court Judge Lilia Purugganan herself said the new label may serve to erode public confidence in the products in question.

In response, the FDA said, “DoH Administrative Order 2010-0008 was issued mainly to inform the public that food/dietary supplements are not drugs and should not be used to treat disease.”

Dr. Rabe said he supports such government initiatives. But he finds the label too long and suggests a simpler one: “Ang [supplement] ay walang napatunayang bisa para sa sakit niyo” (This [supplement] has no proven benefit for your ailment).

As things stand, the old qualifier “no approved therapeutic claims” stays.

But Dr. Rabe says there are ways to counter this advantage for supplement products:

“We... plan to disseminate evidence-based medicine to our doctors to prevent irresponsible prescription of these medications. That’s because even some doctors sell these supplements in their clinics.”

A drug has a definite intended effect on the body, proven by a study. A food supplement is literally an add-on to one’s oral intake.