# FDA Letter on MSM



## JeanG (Oct 20, 1999)

The url for these letters is at: http://www.fda.gov/cder/warn/cyber/cyber2000.htm You have to look at it in Acrobat ReaderDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service___________________________________________________________________________________Food and Drug Administration7520 Standish Place - Room 254Rockville, MD 20855September 21, 2000Ref. No. 00-HFD-310I-028Mr. Scot BrownNatureï¿½s Alternatives3531 W. Glendale Avenue #266Phoenix, AZ 85051Dear Mr. Brown:This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at theInternet address: http://www.naturesalternatives.com and has determined that the various MSM productscontaining methylsulfonylmethane as an active ingredient including MSM EYE/EAR DROPS, MSM BULKPOWDER, MSM CAPSULES, MSM ï¿½TORPEDOï¿½ TABLETS, THREE IN ONE Arthritis Formula, FOURIN ONE Joint Rebuilding Formula, and other products including DMSO, CETYLMYRISTOLEATE, DHEA,and ORGANIC DULSE IODINE being offered are promoted for conditions that may cause them to be drugsunder section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)]. The productsmay be considered drugs because the therapeutic claims as shown on your web site establish their intendeduse as drugs.Examples of some of the products and claims observed on your web site include: ï¿½ï¿½MSM eye ear drops forpink eyeï¿½ï¿½, ï¿½ï¿½MSM EYE/EAR DROPSï¿½used to relieve allergies; dry itchy conditions of the nose; andconditions of the earsï¿½ï¿½; ï¿½ï¿½MSM sulfur affects diabetes, arthritis, emphysema, nerve damage, dry skin,migranes, asthma, candida, constipationï¿½ï¿½ (MSM BULK POWDER, MSM CAPSULES, MSMï¿½TORPEDOï¿½ TABLETS, THREE IN ONE Arthritis Formula, FOUR IN ONE Joint Rebuilding Formula);ï¿½ï¿½MSM BULK POWDERï¿½parasite cleanseï¿½ï¿½; ï¿½ï¿½DMSOï¿½provide arthritis pain relief and reduceinflammationï¿½treatment of interstitial cystitisï¿½ï¿½, ï¿½ï¿½bursitis, burns, cancer, herpes and osteomyelitisï¿½ï¿½;ï¿½ï¿½CETYLMYRISTOLEATEï¿½attacks the cause of arthritisï¿½ï¿½; ï¿½ï¿½DHEAï¿½demonstrated in ailments suchas arthritis, lupus, asthma, and HIVï¿½cancer and chronic fatigueï¿½ï¿½; ï¿½ï¿½ORGANIC DULSEIODINEï¿½prevention of cancerï¿½treatment of thyroid diseaseï¿½ï¿½.Furthermore, FDA has no information that your products are generally recognized as safe and effective forthe above referenced conditions and therefore, they may also be Anew drugs### under section 201 (p) of theAct [21 USC 321(p)]. New drugs may not be marketed in the U.S. without prior approval from FDA asdescribed in section 505 (a) of the Act [21 USC 355(a)]. FDA approves new drugs on the basis of scientificdata submitted by a drug sponsor to demonstrate that the drug is safe and effective.FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs orthat these drugs are not in compliance with the law. Many of these products may be legally marketed asdietary supplements or as cosmetics if certain therapeutic claims are removed from the promotional materialsand the products otherwise comply with all applicable provisions of the Act and FDA regulations.Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietarysupplements may be legally marketed with claims that they are intended to affect the structure or function ofthe body (structure/function claims) if certain conditions are met. Claims that dietary supplements areintended to prevent, diagnose, mitigate, treat, or cure disease (disease claims) excepting health claimsauthorized for use by FDA, may not be made as they cause the products to be drugs. The intended use ofa product may be established through product labels and labeling, catalogs, brochures, audio andvideotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA haspublished a Final Rule intended to clarify the distinction between statements allowed as structure/functionclaims and those that represent disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html.[/URL] In addition, only products that are intended for ingestionmay be lawfully marketed as dietary supplements. Topical products and products intended to enter into thebody directly through the skin or mucosal tissues, such as transdermal or sublingual products, are notdietary supplements. For these products, disease or structure/function claims may cause them to be newdrugs.Additional information is available in Title 21, Code of Federal Regulations, (21 CFR) Parts 310 and 330-358.These parts include the Final Rules for various OTC ingredients or products that may or may not be legallymarketed without prior approval.This letter is not intended to be an all-inclusive review of your web site and products your firm may market.It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act andits implementing regulations.If you need additional information or have questions concerning any products distributed through yourweb site, please contact FDA. You may reach FDA electronically (E-mail) at Heller###CDER.FDA.GOV, oryou may respond in writing to Mr. Robert Heller, Compliance Officer, Food and Drug Administration, HFD-312,7520 Standish Place, Rockville, MD 20855 or by telephone at (301) 594-1065.Sincerely yours,David J. Horowitz, Esq.Acting DirectorOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration[This message has been edited by JeanG (edited 10-03-2000).][This message has been edited by JeanG (edited 10-03-2000).]


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## Mike NoLomotil (Jun 6, 2000)

EXCERPT:"Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietarysupplements may be legally marketed with claims that they are intended to affect the structure or function ofthe body (structure/function claims) if certain conditions are met. Claims that dietary supplements areintended to prevent, diagnose, mitigate, treat, or cure disease (disease claims) excepting health claimsauthorized for use by FDA, may not be made as they cause the products to be drugs. The intended use ofa product may be established through product labels and labeling, catalogs, brochures, audio andvideotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA haspublished a Final Rule intended to clarify the distinction between statements allowed as structure/functionclaims and those that represent disease claims. "..._____That is always the tricky part for supplement vendors, that area of what constitutes the definition of what can be legitamtely said to "effect the structure and function" of the body. There are indeed many products claiming to affect structure or function in a way that excludes them from exemption as supplements instead constituing drug claims, and it is good the FDA is working on making thios clearer for both distrubutors and consumers. Far too many braod claims are made, and it is hard to discriminate the legitimate claims from the puffery.[This message has been edited by Mike NoLomotil (edited 10-03-2000).]


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