Download Ms. Deborah ShurTrmk=, Esq. Senior Vice President ReguJatory Affairs

Publii He+h servke
FoMand (Irug Admhistration
college Pfrk, MD 20740
Ms. DeborahShurTrmk=, Esq.
SeniorVice PresidentReguJatory
Affairs
Rexall,Inc.
6111BrokenSoundP@way,,N.W.
BocaRaton,Florida 33487-3613
DearMs. Trinker:
This is in responseto your lettersof June13,2003to the FoodandDrug Admin.&t&ion
(FDA) pursnantto 21 U.SL!. 343(r)(6) @&ion 403(r)(6)of the FederalFood,Dkt@,and
Cosnktic Act (theAct)). Your submissionstatesthat Rexall, Inc. is makingthe ! !
following claimsfor the pro+% Vuemax~ Intensive:
“As we age,the chancesof developingagkelated eyecouditionsincrease.:
“...basedon the AgeiRelatedEye DiseaseSt&y (AREDS)...”
“...patiats who we& at high risk for age-relatedeyeconditons...”
21 U.S.C.,343(r)(6)makes+ar that a statementmcludedin lab+ng underthe au#~ority
of that sectionmay not claim to-diagnose,mitigate,treat,cure*or preventa spec@z
diseaseor classof d&eases.; The statementsthat you aremaking-for this product~suggest
that it is intendedto Ire&, prevent,or n@ig&edisease,namely,~1a.r degenemdon.
Theseclaimsdo not,meetthe requirementsof 2 I U.S.C. 343(r)@&Thesechums&ggest
that this productis intendedfor useas a drug wit.& the keening of 21 U.S.C.
321(g)(l)(B), andthat it is subjectto regulationt&der the drugprovisionsof the Act. If
you intendto makxlaims of ‘thisnature,you shouldcontactFDA’s Centerfor Dr@g
Eval~tion ax&Research
(GDER), Of&e of Cor&liance,BFD3 10, Montrose$&ro II,
11919Rockville Pike,Rockville, Maryland20852.
_.^.j
Page2 - Ms. Debor&Shur T&&a, Bq.
:
Pleasecontactus if we maybe of krther assistamx.
Susan3. Walker,M.D.
Acting.Dire$or
Division of @%ry SupplementPrograms
Office of N~tritimal products,Iabeling
andDieta$ySupplement
Centerfor F&d S&ty
andAppliedNtitrition
Copies:
FDA, Centerfor Drug Eval&ion and,Research,
Office of Compliance,HFD-300
FDA, Of&x of the A.ssoci@e
Commissionsfor I+g-t&ory A&&s, Of&e of
Enforceme&HFC-200
FDA, FloridaDistrict Ofticy, Office of Compliance,,$?R-SE240
:
June 13,2003
Food and Drug Administration
Office of SpecialNutrition~s (HFS-450)
Center for Food Safety and Applied Nutrition
200 C Street, SW
washington, DC 20204
Dear Sirs:
Notice-ishereby given,that Rexalf,--Inc.(“Rexall’ located at 6111 Broken Sound ;
Parkway, N. W ., Boca Raton, Florida 33487 has marketeda’dietary supplement ’
under the Rexall brand name bearing the following statement(s)on the label and/or
in the labeling:
VuemaxTMIntensive: AREDS-BasedFormula. What can VuemaxTMIntensive do
for you? As we age, the &@.xs of developing age-relatedeye conditions increase.
Vuemax Intensive is an eye ,carenutritional supplement&&has been specifically ’
formulated to help reduce some of the age-relateddeclines in eye health. It’s a
combination of vitamins and minerals basedon t&e Age-&Zq&d Eye DiseaseStt&y
(AREDS), conducted.by the National Eye Institute (NEI). Flus, Vuemax Intensive
contains the extra nutrients Lutein and Zeaxanthin. Thesenutrients are naturally
occurring in the eye and provide protel;tiun by absorbingand filtering harmful light.
What is AREDS (Age-RelatedEye DiseaseStudy)? AREDS isa recently compl*ed
lo-year clinicalstudy supportedby the NEI.(an agencywithmthe Federal Gove&ment’s
National Institutes of Health). This study found that patients who were at high risk for
age-relatedeye conditions be&&.% significantly,when treated with a high potency
combination of antioxidant vitamins, zinc and copper.
Why does Vuemax Intensive include Lutein and ieaxanthin? Commonly found in dark
leafy greenslike kale and spinach,Lutein and Zeaxanthin are two beneficial caro&noids
6111 Broken Sound Parkway, N.W. * Boca Raton * Florida .33487-361i3
Td, 561-24l-9400 Fax 561-995-5188
Food and Drug .&lminis#ration
June 13,2OU3
l
Page
2
that have been shown to be important for eye health. Thesetwo nutrients are found in the
retina, macula and lens of the eye. People with diets high in Lutein and Zeaxanth@may
have a reducedrisk of developingsome age-relatedconditions, It is important to note
that the levels of these carotenoidsfound in Vuemax Intensive generally can only be
auainedby supplementatioriandnot through diet bone.
The undersignedcertifies that the information containedin this notice is complete;and
accurateand that Rexall has substantiationthat 7 statementis truthful and not I
misleading. Pursuantto 8 lOl.93 (a)(l), two copresof this notification are encl&ed.
Cordially,
Deborah Shur Trinker, Esq.1
Senior Vice President
Regulatory Affairs
_
Enclosures
6111 Broken Sound Parkway, N.W. * Bma Raton. Florida. 33487-3613
jTel561-241-9400 F& 995-5188