J Toxicol Environ Health A. 2008;71(21):1415-29.
Splenda alters gut microflora and increases intestinal p-glycoprotein and cytochrome p-450 in male rats.Abou-Donia MB, El-Masry EM, Abdel-Rahman AA, McLendon RE, Schiffman SS.
Department of Pharmacology, Duke University Medical Center, Durham,
North Carolina 27708, USA. [email protected]
Splenda is comprised of the high-potency artificial sweetener sucralose (1.1%) and the fillers maltodextrin and glucose. Splenda was administered by oral gavage at 100, 300, 500, or 1000 mg/kg to male Sprague-Dawley rats for 12-wk, during which fecal samples were collected weekly for bacterial analysis and measurement of fecal pH. After 12-wk, half of the animals from each treatment group were sacrificed to determine the intestinal expression of the membrane efflux transporter P-glycoprotein (P-gp) and the cytochrome P-450 (CYP) metabolism system by Western blot. The remaining animals were allowed to recover for anadditional 12-wk, and further assessments of fecal microflora, fecal pH,
and expression of P-gp and CYP were determined. At the end of the 12-wktreatment period, the numbers of total anaerobes, bifidobacteria,lactobacilli, Bacteroides, clostridia, and total aerobic bacteria were significantly decreased; however, there was no significant treatment effect on enterobacteria. Splenda also increased fecal pH and enhanced the expression of P-gp by 2.43-fold, CYP3A4 by 2.51-fold, and CYP2D1 by 3.49-fold. Following the 12-wk recovery period, only the total anaerobes
and bifidobacteria remained significantly depressed, whereas pH values, P-gp, and CYP3A4 and CYP2D1 remained elevated. These changes occurred at Splenda dosages that contained sucralose at 1.1-11 mg/kg (the US FDA Acceptable Daily Intake for sucralose is 5 mg/kg). Evidence indicates
that a 12-wk administration of Splenda exerted numerous adverse effects, including (1) reduction in beneficial fecal microflora, (2) increased fecal pH, and (3) enhanced expression levels of P-gp, CYP3A4, and CYP2D1, which are known to limit the bioavailability of orally administered drugs.
Source: Citizens for Health
Chairman of Citizens for Health Declares FDA Should Review Approval of
New Study of Splenda and Sucralose Reveals Shocking New Information
About Potential Harmful Effect on Humans
MINNEAPOLIS, Sept. 22, 2008 (GLOBE NEWSWIRE) — James Turner, chairman
of the national consumer education group Citizens for Health expressed
shock and outrage after reading a new report from scientists at Duke
University. “The report makes it clear that the artificial sweetener
Splenda and its key component sucralose pose a threat to the people who
consume the product. Hundreds of consumers have complained to us about
side effects from using Splenda and this study, published this past week
in the Journal of Toxicology and Environmental Health Part A, confirms
that the chemicals in the little yellow package should carry a big red
warning label,” said Turner.
Among the results in the study by Drs. Mohamed B. Abou-Donia, Eman M.
El-Masry, Ali A. Abdel-Rahman, Roger E. McLendon and Susan S. Schiffman
is evidence that, in the animals studied, Splenda reduces the amount of
good bacteria in the intestines by 50%, increases the pH level in the
intestines, contributes to increases in body weight and affects the
P-glycoprotein (P-gp) in the body in such a way that crucial
health-related drugs could be rejected. Turner noted that the P-gp
effect “could result in crucial medications used in chemotherapy for
cancer patients, AIDS treatment and drugs for heart conditions being
shunted back into the intestines rather than being absorbed by the body
The study was conducted using male rats over a period of twelve weeks.
The manufacturers of Splenda also used a rat study when they applied for
and received approval to market the product from the U.S. Food and Drug
Administration. At the time, the findings from their rat studies were
extrapolated as to possible effects on humans. This is standard FDA
practice and this study is consistent with that practice.
Turner said, “This report followed accepted policies and procedures and
the results make clear the potential for disturbing side effects from
the ingestion of Splenda. It is like putting a pesticide in your body.
And this is at levels of intake erroneously approved by the Food and
Drug Administration. A person eating two slices of cake and drinking two
cups of coffee containing Splenda would ingest enough sucralose to
affect the P-glycoprotein, while consuming just seven little Splenda
packages reduces good bacteria.” Although the effect of consuming
Splenda does not result from a one time use, the side effects do occur
after accumulated use. Turner also noted unmistakable evidence that
Splenda is absorbed by fat, contrary to the claims of Johnson & Johnson.
Turner announced, “We are calling today on the FDA to immediately accept
our petition filed over a year ago and initiate a review of its approval
of sucralose and to require a warning label on Splenda packaging
cautioning that people who take medications and/or have gastrointestinal
problems avoid using Splenda. The new study makes it clear that Splenda
can cause you to gain weight and lose the benefits of medications
designed to improve and protect your health. The FDA should not continue
to turn a blind eye to this health threat.”
Citizens for Health will testify in Sacramento, CA, on October 3, 2008,
before the California Assembly Committee on Health which is examining
the use of deceptive advertising to promote sales of potentially
unhealthy food additives, particularly artificial sweeteners.
About Citizens for Health
Citizens for Health (www.citizens.org) is an international non-profit
consumer advocacy group working to broaden healthcare options, create an
integrative health system based on wellness, and advance the freedom to
make health choices. The group promotes the fundamental policies needed
to improve health choices and information in the U.S. and
internationally. The group works with grassroots and education
organizations and partners to ensure consumer access to dietary
supplements, safe foods, a healthy environment and a wide range of
healing therapies. Citizens for Health fosters active citizen leadership
and organizes natural health consumers to create political and
legislative solutions that support those rights.
CONTACT: Citizens for Health