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‘Therapeutic claim is misleading’

/ 10:09 PM August 02, 2013

It is with great concern that we write about an advertisement about Arthrite, which appeared in the News section of the July 8 issue of the Inquirer. The ad claimed that Arthrite is “the first traditional medicine for joint pain approved by FDA with therapeutic claim.”

Per the records of the Food and Drug Administration, Arthrite is registered as a food supplement (Reg No. FR-72400), not as a drug. As such, the law requires that a prominent label stating that the medicine has “no approved therapeutic claim” should be carried on its wrapping. The label cannot state otherwise.

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For the Arthrite makers to say that their therapeutic claim has approval from the FDA is erroneous and misleading! An approval of therapeutic claim is only given by the FDA to substances that are considered drugs. This approval requires very strong evidence of safety and efficacy, produced through a series of large and rigorous nonclinical studies and clinical trials. Unfortunately, supplements do not undergo such rigorous processes and are not required to present any such evidence.

They are also not tested by the FDA for such claims. While there may be a small clinical trial showing some benefits from certain ingredients of a supplement, still therapeutic claims should be viewed with caution, as the evidence is not considered strong enough for the FDA to approve it as a drug. This regulation is there to protect the public.

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We, at the Institute of Herbal Medicine, National Institutes of Health, support the use of herbal medicine for the health of the Filipino people. Our goal is to improve the health of Filipinos by providing safe, effective and quality herbal medicine products that have been scientifically validated and are affordable and accessible. We do recognize that herbal medicines, if they are to be used as medical treatment, need to be subjected to and pass the same high

standards and rigorous process before they can be registered as safe and effective drugs that the consumers can use with peace of mind.

We deplore the marketing tactics of some herbal supplements that prey on the vulnerability of the public for their own profit. We urge manufacturers, distributors and sellers of supplements to be responsible with their statements as we are not dealing with something trivial—we deal with the health and wellbeing of people!

We also urge the Advertising Board to regulate the advertisements in the interest of the consuming public.

—CHARISSA MIA SALUD-GNILO, MD,

research faculty, CECILIA C. MARAMBA-LAZARTE, MD, MScID, director, Institute of Herbal Medicine,

National Institutes of Health, University of the Philippines Manila

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TAGS: Advertising, Arthrite, Food and Drug Administration, letters to the editor, opinion, Therapeutic claim
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