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DEPARTMENT
OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Washington, DC 20204
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Mr. R. Elliott Dunn, Jr.
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,GeneralCounsel
Strictly Supplements,Inc.
2920 N. Green Valley Parkway
Building 3, Suite 321
Henderson,Nevada 89014
Dear Mr. Dunn:
This is in responseto your letter of December22, 2000 to the Food and Drug
Administration (FDA). Your letter respondsto our letter to you dated October 13,
2000 concerning your July 7, 2001 submissionpursuant to 21 U .S.C. 343(r)(6) (section
403(r)(6) of the Federal Food, Drug, and CosmeticAct (FD&C Act)) for the product
Cm-A-Sol.
In your letter, and the letter from Ralph Fucetola,III on your behalf that you included
with your letter, you statethat you disagreewith our determinationthat your product can
not be lawfully marketedas a dietary supplementbecauseit violates the FD&C Act. The
agencyhas consideredthe information in your most recent letter and nothing in your
letter, nor in the letter from Mr. Fucetola, persuadesus that our conclusion that this
product is not a dietary supplementis wrong. The continued marketing of this product as
a dietary supplementviolates the FD&C Act and may subjectyou or the product to action
under the FD&C Act without further notice.
Pleasecontact us if you have any questionsregarding this matter.
Sincerely,
J
John B. Foret
Director
Division of Compliance and Enforcement
Office of Nutritional Products,Labeling
and Dietary Supplements
Center for Food Safety
and Applied Nutrition
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Page2 - Mr. R. Elliott Dunn, Jr.
Copies:
FDA, Office of Compliance,Center for Drug Evaluation and Research,HFD-300
FDA, Office of the AssociateCommissionerfor Regulatory Affairs, Office of
Enforcement,HFC-200
--F-DA~-SanFranciscoDi-s~rid-OMicerOfftceo*.~pl~anc~~R-P~~~O
FDA, Florida District Office, Office of Compliance,HFR-SE 240
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EL: (702) 547-9009
trictly
1 upplements;.
Tfyl
Inc.
?920 N.;Green Val!ey Parkway, Bldg. 3,Suite 321
Hendhson, NV 89014
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FAX (702) 898-7.103
.. December22,26bO
Bv Certified Mail
Mr. John B. Foret, Director
Division of Compliance andEnforcement
Office of Nutritional Products;Labeling
and.DietarySupplements
Center for Food Safety and.Applied Nutrition
200 C StreetSW
Washington,D.C. 20204
lw:
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Notice of Use of 8 403(r)(6)
Statements on Dietary Supplement Label
and Labeling - C&A-Sol
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Dear Mr. Foret:
Thank you for your October 13,200Oresponseto my September2 1,200Oletter, requesting
clarification of statementscontained in your September 11, 2000 letter. SSI has reviewed and,
consideredthe conclusionsset forth in your September 11 letter, as clarified by your October 13
letter.
First of all, baseduponyour statementthat your “opinions andconclusionsin this letter and
the letter of September11,200Oarecon.Gstentwith agencypolicy andpractices” andwere provided
by you in your “offkial~capacity as Director, Division of Compliance-andEnforcement, @fke of
Nutritional Products, Labeling, and Dietary Supplements,Center for Food Safety and Applied
Nutrition”; SSI understandsthat yo.uropinions and conclusionsreflect the official position of the
FDA withrespect to the mattersyou address.Ifthis is not correct,I would.appreciateyour advising
me.
Secondly,SSIis awareof the decision ofthe United StatesCourt of Appealsin Pharmanek
v. Shalala, 221.kF.3d 1151. (lOti Cir. 2OOO),which you point out...While this decision does-lend
supportto your statedconclusionthat any of the product’s individual componentsmaybe anc’article
that is approved as a new drug” within the meaning of 21 U.S.C. 321(ff)(3)(B), this position is
contrary to the FDA-s prior interpretation that approval of a new drug-is an.approval’of an entire
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product only, andnot an active ingredient of the product. .This position is alsocontraryto decisions
of the United-StatesSupreme Court, which have held that new drug approval,covered an entire
product. Additionally, the Tenth Circuit remandedthe Pharmanex case to the United States
District Court for the consideration of the issueswhich were raised,but.not decided, before the
appeal was taken Therefore, SSI doesnot believe that this decision merits the reliance the FDA
seems.to place upon it.
Third you acknowledgethat the claims which SSImakesaboutCitr-A-Sol (“Helps maintain
normal function of brain cells and promote a feeling of well-being” and “. . .,to help maintain the
normal function of brain cells, which,tends to promote the feeling of well-being and enhancesthe
quality of life . . .‘+are structure/functionclaims. This fact is the & reasonfor SSI’s notification
letter datedJuly 7,200O. SSI would not have beenrequired to notify the FDA had it chosennot to
make such claims about Cm-A-Sol.
You identify a letter on SSI letterhead as the information that the FDA considers as
indicative,that Cm-A-Sol is promoted and marketedin a mannerthat evidencesthat it is intended
for use as a drug. You say your conclusion is basedupon a belief that Citr-A-Sol was developed
basedupon a liquid deprenylproduct developedby DiscoveryExperimentalandDevelopment,Inc.
that Citr-A-Sol is the sameproduct as liquid deprenyl;that it is marketedto the samecustomersas
liq,uid deprenyl; and that liquid deprenyl was -found to’ be a prescription drug by a jury in the
criminal caseof United Statesv. Kimball. This conclusionassumesthat all of the beliefs on which
it is basedare mattersof fact. This is an erroneousassumption. Citr-A-Sol was developedusing
knowledge.gainedby Discoverv Exnerimental and Develonment.Inc. when it develoneda liauid
denrenvluroduct. Citr-A-Sol is not the same product as-Discovery’sliquid deprenyl and-itwas not
promoted as the same’product, but was offered as a different product, and without any claim or
suggestion’thatit was intended for use as a drug. Nor was the offer to sell Citr-A-Sol limited to
customerswho might havepreviouslypurchasedliquid deprenyl,but rather,it Wasoffered to a much
broader group of potential purchaserswho had previously purchasedother dietary ‘supplements
developedand marketedby Discovery. Finally, as you must know, the jury verdict in the.caseof
United Statesv. Kimball was basedupon the evidenceintroduced in the trial of that,case,and is
limited to that evidence. Suchverdict is irrelevant to any considerationof Citr-A-Sol’s intended
use. SSI promoted and marketedC&r-A-Sol solely as a dietary supplement,and hasnot suggested
in any way that it is intended foi- any purpose other than as a dietary supplement..Any:suggestion
that C&r-A-Sol may be used to treat a disease would be made without any authoriZation or
encouragementfrom SSI: As a-matterof fact, SSI has expresslydisclaimed the use ofCitr-A-Sol
as‘treatmentfor any disease,or for any other usethat would suggestthat it is intended for use as a.
drug.
Eourth-SSIgatheredsubstantialscientific evidence,,aswell as obtained expert opinions, in advanceof its decision-tomarket Citr-A-Sol as a dietary sup@nent. All of that evidence,and the
opinions from scientific experts,support SSI’s position that all of theingredients in C&r-A-Sol are
ingredientswhich meet the definition of dietary supIjlernents.containedin 21 USC. $321(ff)(l).
Based.upon that evidenceand those opinions, SSI believes that the ingredient selegiline qualifies
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under suchdefinition as an extract,of a “botanical”, andthat the other ingredientssimilarly satisfy
one, or.more, of- the defined ingredients of dietary supplements. If this is true, then’ it is not
necessary,that in addition, either selegiline, or any of the other ingredients,must alao satisfy the
definition of “dietary substance”under 21 U. SC. 5 ‘321(ff)( l)(E). Further, SSI is not aware of any
generallyrecognizedscientific evidencethat selegilineitself may result in seriousadversereactions
when used in combination with certain drugs, foods or drinks. To’the contrary,SSI is aware of.
generallyrecognized.scientificevidencethat selegiiineitself hasnot resultedin any seriousadverse.
reactionswhen usedin combination with certain drugs,foods or drinks, but rather, is safe for use
.A
as a dietary supplementaccordingto the directions for such use..
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Additionally, your assertionsthat CitriA-Sol is a drug, a new drug, anunapproved,newdrug,
and therefore illegal for introduction into interstate commerce, and that a dietary supplement
containing seiegiline is therefore adulterated are consideredto be unwarranted on any factual or
legal basisthat SSIis awareof. Citr-A-Sol-hasneverbeendeterminedby the FDA to be a drug, nor
has SSI even soughtFDA approvalfor Citr-A-Sol asa new drug; As mentioned above,SSI makes
no claims that Citr-A-Sol isintended for any useother than as a dietary supplement. And, asto the
assertionthat a dietary supplementcontaining selegiline is thereby adulterated;such assertionis
simply.groundless. If that is a position the FDA wishes to pursue,then it appearsthat under 21
U.S.C. 8 342, the burden is upon the United Statesto establishsuch adulteration.
Finally, SSIdoeshaveconcernsfor consumersafetyand would not knowingly distribute any
product that jeopardized the safety of the consumerof any of its products. This concern,however,
was not the reasonthat SSI suspendeddistribution of Citr-A-Sol. Rather, the reasonSSI suspended
distribution was the threat of the FDA contained in your September11,200Oletter, to take action
against SSI and C&r-A-Sol without any warning or notice, which you have now representedto be
an official position of your agency.
In summary,SSI strongly disagreeswith the conclusionsthat you reachin your letter: As
pointed out at the beginning of this response,SSI believesthat the basic assumptionsfrom which
you begin are fatally flawed. SSI believesthat Citr-A-Sol. is a bona fide dietary supplement;and
that it can marketed’assuch. SSI has not utilized any promotional or marketing .information to
suggestthat Citr-A-Sol is intended for useas anything but a dietary supplement,nor doesit intend
to do so.
Sincerely,
R. Elliott Dunn, Jr.
GeneralCounsel
3
RALPH FUCETOLA III, J.D.
Attorney at Law
58Plotts Road
Newton,NJ 07860
973-300494
Voice Mail: 973-267-4400 x 5016
Fax: 9733006486
[email protected]
www.vitaminlawver.com
October3,200O
JohnB. Foret
Director
Division of ComplianceandEnforcement
FoodandDrug Administration
Washington,DC 20204
DearMr. Foret
I havereviewedyour letter datedSeptember11,200Osentto Striotly Supplements,Inc. (S.S.I.) with regardto CitrA-SOP.
Firstly, the letter appearsto be a letter horn an employeeofthe FDA under21CFR10.85ratherthan an official letter
under21USC33715USC3553,2lCFR3101.90andas set forth underthe Dietary SupplementHealth andEducation
Act of 1994(DSHEA).
UnderDSHEA, the FDA must follow the proceduresset forth, Notification, Hearingif requested,andfollow
throughwith the administrativeprocessof proving their position underDSHEA. The FDA hasthe burdenof proving
their positionasto whetheror not Cur-A-Sol is a Dietary Supplementor not or is labeledproperly.
In my previouscorrespondence
with S.S.I.,I renderedan opinion that Citr-A-Sol aspresentedandas labeledwas a
Dietary Supplement.The fact that thereis experttestimonyfrom notedScientistsandDoctorsthat all the ingredients
-within Citr-A-Sol qualify underDSHEA asDietary Supplementsreaffirms my positionthat Citr-A-Sol is indeeda
supplementas labeled,not a drug, assuggestedby the FDA.
You suggestthat Selegelineis an active ingredientwithin an approveddrug,thereforehaving Selegelinewithin CitrA-Sol makesCitr-A-Sol somehowa drug by association.This was not the intentof Congressin adoptingDSHEA.
Congress,respondingto public demand,intendedthe widest availability of dietarysubstancesandtruthful
informationaboutthem.
I havebeencleariy advisedthat the active ingredientwithin FDA approveddrugsis not what you suggest,
Selegeline,but in fact the chemicalentity Selegeline Hydrochloride is what is presentin FDA approveddrugs. I
havealsobeenadvisedthat experttestimonyadmittedin FederalCourt in the case US vs Kimball et al., revealed
that the chemicalentity Selegeline Hydrochloride is not the samechemicalentity as Selegelineor Selegeline
Citrate. This in itself is enoughreasonto statethat the FDA approvedSelegelineor Deprenyltype product is
definitely;notthe sameasthe Cur-A-Sol supplementwhich is intendedfor humaningestionas a dietary substance.
In USvs Generex the SupremeCourt statedthat a productor drug productconsistsof the entireproductnot any one
ingredientor designatedactive ingredient. Also reflectedin Generexis that a drugproductusing the samenamed
chemicalas an active ingredientmadeby different manufacturersis in fact not the samedrug. The FDA obviously
agreeswith the SupremeCourt regardingGenerics,as the FDA demandsap individual New Drug Application for
eachGenericor allegedduplicatedrug productand requiresextensivebio-equivalencytestingto prove eachGeneric
Drug Application is an equivalentdrug productto the approveddrug. Many GenericDrug Applicationsto the FDA
arerefusedbecauseof testing resultsrevealingthe productsare not the sameunderextensivetesting.
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The Generexcaseclearly saysto me, andI am sureanyoneelse,that the active ingredientor chemicalwithin any
productwhetherit be a drugor not is in fact not a drug by itself nor controlledby the FDA, evenif the active
ingredientwerethe samewhich is not the fact in the caseof Strictly SupplementsInc. and C&r-A-Sol.
I havebeenadvisedthat the chemicalentity anddietarysubstanceSelegelineonly normalizesa tissuewithin the
brain calledthe substantiunegru,which in turn protectsbrain cell degeneration.In that regardCitr-A-Sol would
definitely qualify as a nutrientasits action promotesa healthybody, asdoesVitamin C, Calcium,andthe varied list
of nutrientsclassifiedunderDSHEA as dietarysubstances.
I havenot changedmy opinionregardingCitr-A-Sol beinga Dietary SupplementunderDSHEA just becauseMr.
Foret,not actingunderthe requiredregulation,hasa different stance. The productwith its ingredientsis a Dietary
Supplementand labeledproperlyunderDSHEA.
However,in the utmost precautionbecausethe FDA hastakenthe position they have,which I believeis totally
improperandnot within the guidelinesof DSHEA at all, I havesuggestedto’S.S.I.changingthe claims on the label
to say: “This nutrient supportsnormal structureand function andmay improveyour quality of life.” andnothing
regardingmedicalclaims. I think it would be exceedinglydifficult for you to misconstruethat statementasa
medical claim. It is my adviceand opinion that the suggestedstatementis not a medicalclaim in any fashion. Also,
in the utmostprecautionI recommendedthe removalof the old D.E.D.I. logo asthe FDA could misconstruethat
logo as creatinga relationshipto an productwhich did statetruthful medicalclaims.
If C&A-Sol were promotedby S.S.I. asa dietarysupplementproductthat on& claimedthat it may improve quality
of life, I cannotforeseeany complaintthe FDA could haveregardingmy legalstance,adviceandopinion. S.S.I.
may rely uponthis opinion andthe statutorybasisfor the “normal structureandfunction” claim which S.S.I. is
entitledto makeunderDSHEA.
However,if the FDA wantsto hassleS.S.I.you havethe powerto do so andthereis little S.S.I.cando exceptgo
throughthe Court System. As we havelearned,over andover again(see,for example,Pearson v FDA) the
governmentagencyoften losesin Court andthe intent of CongressunderDSHEA is upheld.
To avoid the continuedFDA harassmentof S.S.I.the companyalwayshasthe alternativeto set up a manufacturing
facility in every state,produceand sell Citr-A-Sol within eachstateandtotally avoid any FDA “interstate
commerce”jurisdiction over the companyor its products. Gf course,Congressdid not intendAmericansto haveto
.goto suchlengthsto exercisethe rights that aresecuredby DSHEA. To exercisethoserights oneneedonly havea
productwhich qualifies asa dietarysubstance(which Cm-A-Sol does)anda complying label, stating“dietary
supplement”-- making only allowedStructureandFunctionclaims underthe FDA promulgatedRule. This, in my
opinion, S.S.I.will havedone. I hopethe FDA will reconsiderthe pos,itiontakenin the letter of SeRtember11,200O
to avoid unnecessarylitigation which will not further any legitimateregulatorypurpose,but will only serveto, at
best,temporarilydelaythe consumer’saccessto a simple dietary substancethat supportsnormalstructureand
function.
cc:
Mr. R. Elliott Dunn, Jr.
GeneralCounsel
Strictly Supplements,Inc.
All rights reserved-- UCC I-207