|
By Paul M. Icamina, Special
Reports Editor
THE claims were running so thick
and fast that the Bureau of Food and Drugs (BFAD) had to issue a
public advisory that food supplements have no medical benefits
except as
additional nutrients.
“Sa madaling salita, ANG MGA
ITO AY HINDI NAKAGAGAMOT [In layman’s terms, THESE DO NOT
CURE],” the advisory said. The all-capital-letter emphasis is that
of BFAD.
It warned that the use or
ingestion of dietary supplements in lieu of regular medication is
not right and may result in complications or side effects.
Dietary supplements (also called
nutritional supplements or nutraceuticals) contain vitamins,
minerals, herbs or other botanicals, amino acids, enzymes and/or
other ingredients intended to supplement the diet.
“Because of the increasing
reports about food supplements that claimed to have therapeutic
effects, we had to issue an advisory last March,” said Melody
Zamudio of BFAD’s Product Services Division’s (PSD) Traditional
Medicine and Health Supplements Unit. “Food supplements are
nothing more than ‘food’ in pharmaceutical dosage.”
“It’s just like eating
ordinary vegetables and drinking fruit juices, except that these are
in capsules, tablets, syrups, powder forms, concentrates and so
on,” said colleague Charmaine Bonus. “Beyond what BFAD says
‘no approved therapeutic claims,’ these are illegal claims.”
In the Philippines, as in the
United States, herbal and other dietary supplements are regulated as
foods. This means that they do not have to meet the same standards
as drugs and over-the-counter medications for proof of safety and
effectiveness.
BFAD oversees the safety of foods
(including dietary supplements), medicines, medical devices and
cosmetics.
The PSD processes and licenses
the sale and distribution of food supplements that undergo strict
analysis, including tests for the absence of synthetic substances
such as aspirin, paracetamol and even pesticide residue.
Thousands of applications are
filed every year and approval takes from three to six months. The
PSD is currently processing applications filed from January to
February. It is relatively cheap—P3,000 initial fee for two years,
renewable at P200 each year.
“We process more than 1,500
products each year, of which 20 percent are initially approved,”
Zamudio says.
There are now 21,310 food
products registered with BFAD, including food supplements and
nutraceuticals. Thirty-two herbal medicines (and over 12,500
pharmaceuticals for humans) are registered.
Last year, there were more than
28,600 applications for food and drugs products.
The process is strict. The
product, for example, must be in the international Generally
Recognized as Safe (GRAS) list.
Among many other requirements, it
should conform to the Recommended Energy and Nutrient Intake (RENI)
dosage per day. More than the RENI standards, the product is
considered a drug and must undergo separate processes for
pharmaceuticals or medicines.
Still, fraudulent claims continue
and BFAD has issued cease-and-desist orders over questionable
broadcast and print advertisements.
BFAD has questioned a product’s
“approved therapeutic indications… for lowering blood sugar
levels, urinary tract infections, bladder and kidney problems.” It
debunked “a breakthrough dietary formulation that helps control
excess carbohydrate intake the natural way.”
“Per our records, the product
is classified as a food supplement. Products classified as such are
not allowed to have claims of therapeutic values,” BFAD warned.
Indeed, BFAD—a Department of
Health agency—specifies, subject to space, the font size (14
points) and type (Arial) and all capital and bold letters for the
“No Approved Therapeutic Claims” label.
The only nutrition claims
permitted relate to energy, protein, carbohydrate, fat, fiber,
sodium, vitamins and minerals.
Health claims must be based on
current scientific substantiation. Any health claim must be
acceptable to health authorities and the claimed benefit should come
from the consumption of a “reasonable quantity” of the food.
BFAD also has strict guidelines
on herbal medicines. Products that cause adverse drug reaction, for
example, or may cause dependence are prohibited.
For products used for more than
30 days, toxicity tests of 90 days are required; products to be used
for more than 30 days are tested on rodents and mice for at least
nine months.
The same strict standards are
true for traditional herbal products. These are preparations from
plant materials whose claimed applications are based on traditional
experience of at least five decades as documented in medical,
historical and ethnological literature.
Evidence of safety is based on
documented prolonged and apparently uneventful use of the
traditional herbal product. Even then, it is not allowed for use in
pregnant, lactating mothers and children below 18 years and should
be labeled as such.
To protect consumers, the first
step is a cease-and-desist order that stops the distribution of a
product that falsely claims therapeutic effects.
The manufacturer or distributor
is required to explain why no administrative sanction should be made
by BFAD’s Legal Information and Compliance Division.
The fine is anywhere from a few
hundred pesos up to P5,000, depending on the violation. A promo
without a BFAD permit is fined P200. For an unregistered drug, the
fine is P5,000 up to P10,000 per product.
Note that it is not on a “per
count” basis, that is, for every single product like a capsule or
tablet illegally sold. Observers say the fines are small, but that
is based on consumer laws and regulations crafted in 1993 that is
about ripe for an update.
BFAD monitors products nationwide
for false therapeutic claims and consumers report fraudulent
products. “Many are actually taking the time to approach us, and
we take action,” said a staff member in the legal division.
“What’s not allowed are therapeutic claims, cures, health
claims.”
“The law doesn’t say how
prominent or how long the ‘No Approved Therapeutic Claims’
should appear on TV ads, and the same goes for radio and print.
Basta mabasa lang at marinig [As long as it is seen and heard].”
|
