NO
APPROVED THERAPEUTIC CLAIM is a disclaimer on the labels of many supplements
that the FDA (Food and Drug Administration) has not verified. When a product bears this disclaimer on the
label, it only means that these food or dietary supplements (F/DS) have no
approved therapeutic or curative effects.
These F/DS were granted market authorization as food products and not as
drugs. As food products, evidence-based or clinical studies on these F/DS need
NOT be submitted to the FDA. However,
all food supplements are required to carry on their labels the phrase “No
Approved Therapeutic Claims” because as food products they are not intended to
treat, diagnose, nor cure diseases. Therapeutic claims can only be made for drug
products authorized by the FDA.[1]
In
the Philippines, manufacturers of
supplements do not need to seek approval from the FDA in marketing dietary supplements. Companies (local or international) can also
claim that their product addresses a nutrient deficiency in the body. Various owners, advertisers, and agents of
food/ dietary supplements are also abusing the use of the disclaimer “No
Approved Therapeutic Claim”. Thus, there
is a growing public concern due to the inaccurate, misleading, and false claims
on the efficacy of some supplements that are in the market today.[2]
There
has been an alarming proliferation in the market of well-commercialized herbal
and alternative medicines which might pose danger to our public health system
and imperil the lives of the unknowing and non-discriminating public. Today, manufacturing firms and distributors
of herbal food and dietary supplements have resorted to utilizing powerful
marketing and advertising tools to entice the public to try and patronize their
products such as tapping showbiz and sports personalities to endorse various
products.[3]
Just
recently, the FDA issued DOH-FDA Advisory No. 2012-008 which warned the public
of “food supplements [that are] being advertised, promoted, and marketed
over the TV as having therapeutic claims.
The endorsers are peddling
testimonials made by people who took the food supplement. The false claim of [some] unscrupulous peddlers even accompanied with
the FDA logo and the Certificate of Product Registration (CPR) as food products
that are flashed on the screen to give semblance of legitimacy. Thus, “The
public is advised to be more discerning about their health and the health products
that they buy.”[4] The regulation of claims attributed to all
health products in general is imbued with public interest as such claims can
influence a person’s belief regarding a particular health product. Reliance on false and misleading claims
regarding a health product may have harmful consequences to a person’s health.[5]
[1]http://www.fda.gov.ph/attachments/article/118031/FDA%20Advisory%20No.%202013-044%20TV%20Ads%20Food%20Supplement.pdf
[2] http://www.doh.gov.ph/node/1325.html
[3] http://www.congress.gov.ph/download/basic_15/HB02189.pdf
[4] Ibid (1)
[5] http://www.metaphilippines.org.ph/phocadownload/Medicines-Transparency-Alliance-MeTA-Philippines-FDA_stand-on-herbal-supplements-2010-June.pdf
