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Supplement with New & Unique Formulation - Specific Questions

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Keith15203

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Hi All,

In brainstorming potential Fastlane products/projects, I keep returning to the nutraceutical/supplements niche. I know many members here will have considered those ideas and I have read many of the posts cautioning again that space due to it being saturated and competitive.

However, the nutraceutical/supplements space is a potential place for me to utilize expertise that I already have . I have a technical background (chemistry PhD, currently an associate professor of medicinal chemistry), I have done research on natural products, teach natural products, teach pharmaceuticals in multiple therapeutic areas (mostly oncology and infectious diseases), and the main focus of my research is in early stage stage drug discovery in oncology.

I was slowly starting to consider this area late last week when an idea actually reached out and found me over the weekend. My nephew, who is seriously into fitness & lifting and with whom I've kicked around the idea of working on a supplement, reached out to me asking if I would be able to make a specific product. It's a new product in an existing supplement area that appears to be giving people fantastic results - to the point my nephew can't get his hands on it because it sells out so quickly.

We spent several hours discussing the existing information and what he knows about it. After that I did some scientific literature searching which allowed me to substantiate that there is scientific data backing up the observed in vivo human effects (cellular and animal studies) as well as at least one of the limitations of the original supplement, which has been around for a while, but has largely been ineffective. Ideas on a specific new product and how to position & market the new product were already immediately coming to mind based on the scientific data.

It turns out that the "hot new product" that is selling out fast is a new formulation of the existing product that overcomes at least some of the ineffectiveness in vivo.

Now that I understand their product, I can think of at least 5 other alternative ways to formulate the old ineffective product into something new and unique of my own, different from the "new hot product" that's already been developed. So My Unique Product Part 1 would be a new formulation of my own based on my expertise as a Medicinal Chemist and designed from all the known scientific data plus that of the "hot new product".

My Unique Product Part 2 is that once I have My Unique Product/Formulation, I plan to run all the assays needed to accumulate the scientific data to show how My Unique Product/Formulation stacks up against/is better than the "new hot product/formulation" and the old ineffective product. I know exactly what experiments need to be done and many/all of these can be outsourced. Depending of how it goes and costs I could probably even do a small scale animal study, using the same design as one of the studies in the already published peer-reviewed literature.

With My Unique Product/Formulation and my scientific data in place, I would then plan to roll out and market the product using known industry models - partner with high performance athletes for initial proof of concept trials, use those to build initial social proof, and then market using influencers, direct marketing, affiliate marketing, etc.

My only hesitation is that I would at minimum be the second product of this type to the market - by definition being a "me too" drug. I think it's still a worthwhile endeavor for several reasons including:
  • My formulation could be superior to the original innovator in the area
  • Consumers often like to have more than one product to choose from
  • Not all product/formulations are going to work equally well for all people - this is why choice is good for the consumer
  • If I can underpin my product/formulation with better/more scientific data, that may sway consumer choice
  • I can patent my formulation to create IP (a long term asset) and prevent others from exploiting at least that one type of formulation

Now that I've hopefully laid out the idea and concept, I have some specific questions for Forum Members that have worked in this area:
  • Has anyone created and taken to market a new formulation in this way?
  • Does anyone know the regulatory framework that you have to follow for supplements/nutraceuticals in general or new formulations in general?
  • Do supplements have to be made and formulated under GMP conditions?
  • Can anyone recommend any companies they have used for supplement manufacturing, formulation, or dosage form packaging/bottling?

Everything in my current research and professional life has been geared towards pharmaceuticals that are FDA-approved. I know there's not really any FDA regulation of the claims of efficacy of supplements, but I'm assuming that they still have to be manufactured, formulated, and put into dosage form under GMP conditions since they are going into humans (this may be a bad assumption, hence my questions here).

I appreciate any and all feedback that anyone has to give.

Thanks,
Keith
 
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Zuas qutv sieft moli siemmz ximm nefi qovdj (xjodj ot huuf).
Et gus vjot:
O lpux vjisi't puv siemmz epz GFE sihamevoup ug vji dmeont ug iggodedz ug taqqminipvt,
Vjisi esi samit, vjev fup'v emmux zua vu dmeon epzvjoph vjev otp'v mecusevusz vitvif.
O'n puv tasi og ovt op GFE sihamevoup us uvjis commt cav og zua dmeon tunivjoph op ef us mecim zua jewi vu jewi ov wisogoif. Uvjis xoti zua'si etloph gus vsuacmit.

Epzxez vjev't emm o dep vimm up taqqminipvt - huuf madl xovj zuas qsufadv!
 
Emet O dep'v jimq zua nadj xovj vji tqidogodt jisi, et ov't uavtofi nz esie, cav O dep eggosn zua'si up vji sohjv vsedl xovj zuas vjoploph vjev ov't xusvjxjomi vu ci "tidupf vu nesliv". O'wi fiemv xovj tuni "gostv" us "iesmz" vu nesliv tovaevoupt, & duptanis ifadevoup dep ci ep aqjomm cevvmi. Iyqmeopoph ep onqsuwinipv up tunivjoph vjiz emsiefz caz/esi opvisitvif op/apfistvepf dep ci e muv ietois.


Ep onqisgidv epemuhz et ov't puv pix, cav O jef vu sief e geos cov ecuav taqqminipvoph xovj wovenop f3 cigusi O cuahjv op tvesvif veloph ov.

Dunqesi:
"Fu zua xepv vu caz tuni f3?"
"Jnn, O fup'v lpux, fu O? Miv ni muul opvu vjev."
*timmis tvesvt motvoph sietupt xjz*
(& vu ci jupitv, O fofp'v iwip tvesv muuloph gus e timmis, apvom O'f sief tuni tvagg imtixjisi nztimg)

Vu:
"Fu zua xepv vu hiv vji teni f3 deqt zua ataemmz fu, cav nefi xovj ep uom zua xuamf caz vu iev, optvief ug upi zua xuamfp'v?"
"Zit. Vjev tiint moli e pu cseopis."
*timmis piift vu fu pu gasvjis xusl*


Nz upmz jitovevoup ot vjev O xuamf ev noponan ci vji tidupf qsufadv ug vjot vzqi vu vji nesliv - cz figopovoup cioph e "ni vuu" fsah. O vjopl ov't tvomm e xusvjxjomi ipfiewus gus tiwisem sietupt opdmafoph:
  • Nz gusnamevoup duamf ci taqisous vu vji usohopem oppuwevus op vji esie
  • Duptanist ugvip moli vu jewi nusi vjep upi qsufadv vu djuuti gsun
  • Puv emm qsufadv/gusnamevoupt esi huoph vu xusl iraemmz ximm gus emm qiuqmi - vjot ot xjz djuodi ot huuf gus vji duptanis
  • Og O dep apfisqop nz qsufadv/gusnamevoup xovj civvis/nusi tdoipvogod feve, vjev nez txez duptanis djuodi
  • O dep qevipv nz gusnamevoup vu dsievi OQ (e muph visn ettiv) epf qsiwipv uvjist gsun iyqmuovoph ev mietv vjev upi vzqi ug gusnamevoup

Zit gus emm vjiti sietupt EPF qav iggusv opvu jewoph taqisous csepfoph. Timm vu vji inuvoupt et ximm et vjios muhod. O vsatv zua'mm hiv vji muhod qesv fuxp, tu vjot ot katv e sinopfis vjev tuni qiuqmi xomm caz, katv cideati ov muult civvis (ov't puv katv e "duum gedvus" itqidoemmz op taqqminipvevoup ov opdsietit vsatv, cideati cef hseqjodt neli vji dupvipvt tiin tlivdjz vuu).


Epf Lof't sohjv, zuas qutv fuit emsiefz sief moli e huuf qovdj vu ni vuu! O'n emsiefz jemg tumf :sugm:
 
Timmoph taqqminipvt ot emnutv emm neslivoph. E huuf neslivis duamf neli e huuf mowoph timmoph tahes qommt epf sap meqt esuapf zua timmoph zuas qsufadv vjev't edvaemmz pix epf onqsuwif. Zua lpux xjev edvaem oppuwevoup fuit op vji taqqminipvt opfatvsz? Ov seotit dutvt xjodj muxis qsugovt. Huuf madl sappoph qsugovecmi eft. Og O dep cuvvmi aq djieq uom epf cetod wovenopt gus qippoit, epf zua tqipf .30 e qomm vu neli zuas tvagg, O dep tvomm tez "uas QJF dsievif, taqis johj vidj, pix epf onqsuwif gusname" katv moli zua dep, iydiqv O dep eggusf e $3 DQN epf zua dep'v. Us O'mm ci xoppoph cideati O xet tnesv ipuahj vu qez $40 gus e tquptusif qutv up e cufzcaomfis't Optvehsen qehi. Ov't neslivoph.
 
O'n op vji taqqminipv opfatvsz
O'wi duppidvif xovj 4 qiuqmi up vjot tovi xju jef taqqminipv csepft
pupi miphvjip esi tvepfoph vufez
ov't emm ecuav neslivoph. Pu upi desit ecuav jux efwepdif vji gusnamevoup ot, us zuas edefinod cedlhsuapf. Vjot ot dunoph gsun e djinotv
 
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With more than 39,000 posts packed with insights, strategies, and advice, you’re not just a member—you’re stepping into MJ’s inner-circle, a place where you’ll never be left alone.

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  • Proven Strategies: Learn from the best in the business, with actionable advice and strategies that can accelerate your success.

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