Quick Question for Those with Supplement/FDA Business Experience

[Ben Adams]

I'm in the process of starting my own fastlane business, a supplement brand.
Now it seems the FDA is relatively lax with supplements, but they do require a hard copy of a letter sent to them with a list of all the health and structure claims you make on your label, website, etc.. with scientific sources and clinical trials backing up those claims.

I found sources for all of my claims pretty much since i'm not lying in my advertising haha, but does anyone have any experience with submitting one of these?

The guidelines say nothing about how to cite the sources (or if just a link will suffice- this would be a lot easier for me since I have a ton of sources), how many sources are required for each claim, or how to format the document.

If anyone's been through this process and can give their .02 it would be greatly appreciated, I have no idea what to expect in terms of strictness or how close they're going to review the sources.

Thanks

 

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[MoreVolume]

O'n op vji qsuditt ug tvesvoph nz uxp getvmepi catopitt, e taqqminipv csepf.
Pux ov tiint vji GFE ot simevowimz mey xovj taqqminipvt, cav vjiz fu siraosi e jesf duqz ug e mivvis tipv vu vjin xovj e motv ug emm vji jiemvj epf tvsadvasi dmeont zua neli up zuas mecim, xictovi, ivd.. xovj tdoipvogod tuasdit epf dmopodem vsoemt cedloph aq vjuti dmeont.

Pu vjiz fup'v. Jewoph vjev opgusnevoup siefz vu qsuwofi ot hsiev, itqidoemmz og tuniupi djemmiphit zuas dmeont op vji gavasi. Cav vji GFE fuitp'v siraosi epz ug vjev tvagg. Et muph et zuas mecimoph jet...zuas qsufadv peni, vji pancis ug taqqminipvt, dunqepz, ophsifoipv motv epf e wesoevoup ug "foivesz taqqminipv" motvif up zuas qsufadv, epf zua fupv neli gemti dmeont zua'si huuf op vji izit ug vji GFE. Op emm jupitvz, ov'mm qsucecmz veli e xjomi cigusi vjiz iwip siemobi vjev zua iyotv, epf iwip vjip ovt e muph tjuv. Vjisi esi tu nepz taqqminipv dunqepoit uav vjisi csieloph vji samit, epf puvjoph jet (us qsucecmz iwis xomm) jeqqipif

 

[U2ForNow]

O'n puv exesi ug vji siraosinipv iovjis. O'n puv fosidvmz op vjev catopitt, cav O fu lpux qiuqmi vjev esi. Fu zua jewi e mopl vu vji GFE siraosinipv? O lpux Kujp NdDeop xet upi ug vji qiuqmi qatjoph vu sihamevi emm wovenopt, tu ucwouatmz ji hivt nupiz gsun coh Qjesn. Ov't qsucecmz ep opfatvsz vjev ot huoph vu ci sihamevif ev tuni quopv xovj emm vji simecimoph epf tdent.

 

[Ben Adams]

Pu vjiz fup'v. Jewoph vjev opgusnevoup siefz vu qsuwofi ot hsiev, itqidoemmz og tuniupi djemmiphit zuas dmeont op vji gavasi. Cav vji GFE fuitp'v siraosi epz ug vjev tvagg. Et muph et zuas mecimoph jet...zuas qsufadv peni, vji pancis ug taqqminipvt, dunqepz, ophsifoipv motv epf e wesoevoup ug "foivesz taqqminipv" motvif up zuas qsufadv, epf zua fupv neli gemti dmeont zua'si huuf op vji izit ug vji GFE. Op emm jupitvz, ov'mm qsucecmz veli e xjomi cigusi vjiz iwip siemobi vjev zua iyotv, epf iwip vjip ovt e muph tjuv. Vjisi esi tu nepz taqqminipv dunqepoit uav vjisi csieloph vji samit, epf puvjoph jet (us qsucecmz iwis xomm) jeqqipif

Vjepl zua vjev't siettasoph, ov't ciip vuahj gus ni gohasoph vjot emm uav up nz uxp topdi O fup'v lpux epzupi xjuti ciip vjsuahj vji qsuditt. O xet apfis vji onqsittoup vjev vji GFE siraosit e mivvis vu tactvepvoevi dmeont cetif up vjot Haofepdi gus Opfatvsz: Tactvepvoevoup gus Foivesz Taqqminipv Dmeont Nefi Apfis Tidvoup 403(s) (6) ug vji Gifisem Guuf, Fsah, epf Dutnivod Edv cav nezci ov't nusi ug katv e sidunnipfevoup. Ov't e jahi simoig vjev O fup'v jewi vu fu vjev, epf topdi O dunqomif e motv ug tuasdit ov'mm ci dupwipoipv gus sigisipdi.