What is inside
“Healthy Hair, Skin & Nails” is a sales name, not a scientific one. Sellers use it for a mixture of nutrients, not peptide drugs. The usual list is five B-vitamins: B1 (thiamine), B2 (riboflavin), B3 (niacin or niacinamide), B5 (pantothenic acid) and B9 (folate). It also holds biotin (B7), choline and inositol. Some sellers add hydrolysed collagen peptides or solubilised keratin. Collagen peptides are small pieces of collagen, the main protein in skin. Keratin is the protein that makes up hair and nails.
There is no official recipe. Each seller decides which ingredients go in and how much of each. Nothing about it is standardised. No drug standard or regulator defines what the name must contain. So the label is the only description of what is inside. The sections below sum up each ingredient. None of them has its own page on this site yet.
The product is a physical mixture of water-soluble micronutrients: thiamine (B1), riboflavin (B2), niacin as nicotinic acid or nicotinamide (B3), pantothenic acid or its alcohol dexpanthenol (B5), folic acid (B9), biotin (B7), choline (usually as the chloride or bitartrate salt) and myo-inositol (C6H12O6, 180.16 g/mol, the subject of an NF monograph). Optional protein-derived components are collagen hydrolysate, a mixture of peptides produced by enzymatic digestion of collagen, and solubilised keratin, which in the one published trial was derived from sheep wool.
No reference standard exists for the mixture, and no compatibility, stability or impurity data were found. The only regulated point of comparison is the FDA-approved parenteral multivitamin Infuvite Adult (initial approval 2003), which per 10 mL dose contains thiamine 6 mg, riboflavin 3.6 mg, niacinamide 40 mg, dexpanthenol 15 mg, folic acid 600 mcg and biotin 60 mcg alongside other vitamins. It contains no choline, inositol, collagen or keratin, is indicated only for preventing vitamin deficiency during parenteral nutrition, and is not this blend. Per-ingredient amounts in blends are set by each seller and are not standardised.
Who made it and when
No one invented this blend. It has no inventor, no developer and no date of discovery. The name belongs to a category of dietary supplements. Products in that category have been sold for many years. The NIH Office of Dietary Supplements notes that biotin supplements “are often promoted for hair, skin, and nail health”. Sellers of research-labelled injections have borrowed the same name for injectable mixtures.
The vitamins themselves are old, well-studied nutrients. Injectable B-vitamin mixtures also exist as approved medicines. The FDA approved Infuvite Adult, a multivitamin injection, in 2003. It is for people fed through a vein who might otherwise become short of vitamins. It is not for hair, skin or nails. No company has developed the hair-skin-nails combination as a medicine.
No originator, patent or investigational new drug application was identified for the combination. The blend is a marketing composition drawn from the dietary supplement category; NIH ODS describes biotin supplements as often promoted for hair, skin and nail health, with support “at best, by only a few case reports and small studies”. The choline and inositol components echo older “lipotropic” B-complex injections rather than any dermatological programme.
Regulated injectable multivitamins provide the only development history of note. Infuvite Adult (initial US approval 2003) is indicated for the prevention of vitamin deficiency in adults and children aged 11 years and older receiving parenteral nutrition, is a two-vial product diluted before intravenous infusion, and carries warnings for anaphylaxis, thiamine hypersensitivity reactions and aluminium content. No sponsor has filed a marketing application for a hair, skin or nail indication for any of the blend’s components.
What the data say
No study has tested this mixture, by mouth or by injection. The evidence for its parts is thin. Biotin deficiency does cause hair loss and brittle nails. But deficiency is rare. A 2017 review found 18 published cases where biotin helped hair or nails. Every one of those people had an underlying condition. In a 1993 chart review, 22 of 35 people with brittle nails said biotin helped. There was no comparison group.
Collagen has a little more data. In a 2017 study, 25 people took collagen peptides for 24 weeks. Their nails grew 12% faster and broke 42% less often. But there was no placebo. In a 2014 trial, 69 women took collagen peptides or placebo for 8 weeks. Skin elasticity improved on the peptides. A 2014 trial of a keratin product in 50 women also found gains. That product also held vitamins and minerals, so keratin’s own role is unknown. For B-vitamins, choline and inositol, no trial for hair, skin or nails was found.
No trial of the combination was identified. Biotin: Patel et al. (2017) systematically reviewed case reports and RCTs and found 18 cases of improvement, all in patients with an underlying pathology such as biotinidase deficiency, brittle nail syndrome or uncombable hair syndrome, concluding that evidence for supplementation in healthy individuals is lacking. Hochman et al. (1993) reported subjective improvement in 22 of 35 (63%) brittle-nail patients in a retrospective, uncontrolled practice review. NIH ODS states that only case reports, in children, support biotin for hair health.
Collagen peptides: Hexsel et al. (2017), an open-label single-centre study with two authors from the manufacturer’s research institute, gave 2.5 g/day of a specific collagen peptide product to 25 participants for 24 weeks and reported a 12% rise in nail growth rate and a 42% fall in broken-nail frequency. Proksch et al. (2014), double-blind and placebo-controlled, randomised 69 women aged 35-55 to 2.5 g or 5.0 g collagen hydrolysate or placebo for 8 weeks and found significantly higher skin elasticity in both active groups. Keratin: Beer et al. (2014) randomised 50 women to 500 mg solubilised keratin plus vitamins and minerals or maltodextrin placebo for 90 days and reported significant hair and nail improvements; two authors were from the ingredient’s suppliers, and the multi-ingredient design cannot isolate keratin. For thiamine, riboflavin, niacin, pantothenic acid, folate, choline and inositol, no trial with hair, skin or nail endpoints was found.
Ingredient: B-vitamins (B1, B2, B3, B5, B9)
These five vitamins are helpers for the enzymes that turn food into energy and build new cells. Thiamine (B1) helps cells use carbohydrates. Riboflavin (B2) and niacin (B3) carry electrons in energy reactions. Pantothenic acid (B5) is part of coenzyme A, which handles fats. Folate (B9) is needed to make DNA. The body does not store much of them. Extra amounts mostly leave in the urine.
Deficiency can show in the skin and hair. Severe niacin deficiency (pellagra) causes a dark rash on sun-exposed skin. Folate deficiency can change the colour of skin, hair or nails. But in the United States these deficiencies are rare. Only about 1% of adults get less niacin than they need. No study shows that extra B-vitamins improve hair, skin or nails in people who are not deficient. Nicotinic acid, one form of niacin, causes flushing at 30 to 50 mg or more. Riboflavin turns urine bright yellow at high doses.
Thiamine is the precursor of thiamine pyrophosphate; riboflavin of FAD and FMN; niacin of NAD and NADP; pantothenic acid of coenzyme A; and folate of the tetrahydrofolate coenzymes used in one-carbon transfer, including the remethylation of homocysteine to methionine and thymidylate synthesis. Absorption is saturable: NIH ODS notes that thiamine absorption declines sharply above 5 mg and that little riboflavin is absorbed from single doses beyond 27 mg, with excess excreted in urine.
Deficiency dermatology is well described but uncommon: pellagra produces a pigmented, photosensitive rash and bright red tongue; folate deficiency produces megaloblastic anemia and can alter skin, hair or fingernail pigmentation. NHANES 2009-2012 found only 1% of adults with niacin intakes below the estimated average requirement. No tolerable upper intake level has been set for thiamine or riboflavin because no adverse effects have been reported at 50 mg/day or more and 400 mg/day respectively. Nicotinic acid causes vasodilatory flushing at 30-50 mg and, at 1,000-3,000 mg/day, hypotension, impaired glucose tolerance, gastrointestinal and ocular effects and hepatotoxicity. Folic acid can mask the haematological signs of vitamin B12 deficiency, a warning carried on the Infuvite Adult label. On FDA’s 503A nominations list, pantothenic acid sits in Category 3 (nominated without adequate support); the other four vitamins are components of approved parenteral products.
Ingredient: Biotin (B7)
Biotin is a B-vitamin that helps enzymes handle fats, sugars and amino acids. Gut bacteria make some. Food supplies the rest. Adults need about 30 micrograms a day. Severe biotin deficiency in healthy people eating a normal diet has never been reported. When deficiency does happen, hair thins, nails become brittle and a red, scaly rash appears around the eyes, nose and mouth. That is why biotin is sold for hair and nails. The NIH says the claims rest, at best, on a few case reports and small studies. Only case reports in children support biotin for hair health.
There is no known toxic dose. But high doses cause a different problem. Biotin gets into many blood tests and gives wrong results. Thyroid tests can read as if a person has an overactive thyroid. A heart-attack test (troponin) can read falsely low. The FDA has reported one death after such a result. Even one 10 mg dose can change thyroid test results within 24 hours.
Biotin is the cofactor for carboxylases in gluconeogenesis, fatty-acid synthesis and amino-acid catabolism. Protein-bound dietary biotin is released by biotinidase and absorbed in the small intestine. The adequate intake for adults is 30 mcg/day, and the daily value on US labels is 30 mcg. Deficiency is rare; its signs include progressive hair loss, periorificial scaly erythematous rash, brittle nails and neurological findings, and biotinidase deficiency is screened for at birth because lifelong oral biotin prevents its consequences.
Efficacy evidence outside deficiency is limited to case series. Patel et al. (2017) found 18 cases, all with underlying pathology, and proposed that such cases are uncommon and that evidence for supplementation in healthy individuals is lacking. No UL has been set because no toxicity has been observed at 10-50 mg/day, or at up to 200 mg/day orally in biotinidase deficiency. The clinically important risk is assay interference: biotin-streptavidin immunoassays for TSH, free T4, troponin, NT-proBNP and 25-hydroxyvitamin D can read falsely high or low; a single 10 mg dose has interfered with thyroid function tests within 24 hours; and FDA continues to receive reports of falsely low troponin results, including one death, and maintains a list of troponin assays that remain subject to the interference.
Ingredient: Choline
Choline is a nutrient, not a vitamin in the strict sense, but it works like one. The body uses it to build cell membranes, to make the nerve signal acetylcholine, and to move fat out of the liver. The liver makes some choline, but not enough, so food must supply the rest. Most Americans eat less than the recommended amount. Even so, true deficiency is very rare in healthy people. When it happens, fat builds up in the liver and muscles can be damaged.
Choline has not been tested for hair, skin or nails. It is in this blend for historical reasons: it was part of older “lipotropic” B-vitamin injections. Too much choline has effects of its own. The safe upper limit was set on the basis of low blood pressure and a fishy body odour. Other effects at high intakes are vomiting, sweating and drooling. Gut bacteria also turn choline into a compound called TMAO, which has been linked to heart disease in observational studies. The FDA lists choline chloride as “under evaluation” for pharmacy compounding.
Choline is a precursor of phosphatidylcholine and sphingomyelin, of acetylcholine, and, via oxidation to betaine, a methyl donor for homocysteine remethylation. Endogenous synthesis as phosphatidylcholine is insufficient to meet requirements. The Food and Nutrition Board set adequate intakes on the basis of preventing liver damage measured by serum ALT; the adult daily value is 550 mg. Deficiency causes muscle damage, hepatic steatosis and NAFLD. In a depletion study of 57 adults consuming under 10% of the AI for up to 42 days, 37 developed liver dysfunction, and in a 15-patient pilot on total parenteral nutrition, adding 2 g choline to TPN resolved NAFLD in all treated patients and none of the controls. NIH ODS nevertheless states that only limited data support choline for treating NAFLD.
Adverse effects at high intakes include fishy body odour (from trimethylamine), vomiting, excessive sweating and salivation, hypotension and hepatotoxicity, and the tolerable upper intake levels were derived from hypotension and body odour. Choline consumption raises TMAO production in a dose-dependent manner, and higher choline intake was associated with increased mortality in the Nurses’ Health Study and Health Professionals Follow-Up Study cohorts. No clinically relevant drug interactions are known. No trial of choline for hair, skin or nails was found. On FDA’s 503A nominations list updated 2026-05-14, choline chloride is in Category 1 (under evaluation) and choline bitartrate in Category 3.
Ingredient: Inositol
Inositol is a sugar-like molecule. The form in supplements is usually myo-inositol. The body makes it, and it is found in many foods. Inside cells it is part of the fatty membrane and of the signals that respond to insulin. Most research on inositol is in women with polycystic ovary syndrome (PCOS), a hormone condition. In those studies it is taken by mouth.
A 2022 review pooled 15 trials of inositol in adults. On average, body mass index fell by 0.41 units, a small change, with the biggest effect in women with PCOS. A 2026 review of 9 trials in 440 women with PCOS found lower testosterone levels. None of this concerns hair, skin or nails. No trial of inositol for any of those was found. Inositol is not on the FDA’s compounding category lists. It has an official monograph in the National Formulary, which is one way an ingredient can qualify for use by compounding pharmacies.
Myo-inositol (cis-1,2,3,5-trans-4,6-cyclohexanehexol, C6H12O6, 180.16 g/mol) is a component of membrane phosphoinositides and of insulin-signalling pathways; NF monograph specifications require not less than 97.0% and not more than 102.0% on the anhydrous basis. The clinical literature concerns oral use in metabolic and reproductive endocrinology. Zarezadeh et al. (2022) pooled 15 controlled trials and found a weighted mean BMI reduction of 0.41 kg/m2 (95% CI −0.78 to −0.04) with high heterogeneity (I2 = 73.9%), larger in participants with PCOS or overweight and with myo-inositol rather than other isomers. Tienforti et al. (2026) pooled 9 RCTs (440 women with PCOS) and found reductions in total and free testosterone and a rise in SHBG, most consistent in normal-weight women.
Nothing in that literature addresses hair, skin or nail endpoints, and no dermatological trial was identified. Any relevance to a “hair, skin and nails” product rests on inference from PCOS hyperandrogenism, which has not been tested. Myo-inositol does not appear on FDA’s 503A category lists; the unrelated niacin ester inositol hexanicotinate is in Category 3. Under section 503A(b)(1)(A)(i), a substance with an applicable USP or NF monograph may be used in compounding without appearing on the bulks list.
Ingredient: Collagen peptides and keratin (some versions)
Some sellers add hydrolysed collagen or solubilised keratin. Hydrolysed collagen is collagen broken into small pieces (peptides) by enzymes. It comes from animal skin, bone or scales. Keratin is the tough protein of hair, nails and wool. In the one published trial, it came from sheep’s wool. Both are foods rather than drugs.
Collagen peptides have small human trials. In a 2017 study, 25 people took 2.5 g a day for 24 weeks. Nails grew 12% faster and broke 42% less often. There was no placebo group, and the collagen maker’s institute helped run it. In a 2014 trial, 69 women took 2.5 g or 5 g a day or placebo for 8 weeks. Skin elasticity rose on collagen. A 2014 keratin trial in 50 women found better hair and nails than placebo. That product also held vitamins and minerals. All of these were taken by mouth. No study has tested injected collagen or keratin for hair, skin or nails.
Collagen hydrolysate consists of peptides of mixed size released by enzymatic digestion of type I collagen; the products studied are proprietary “specific bioactive collagen peptides”. Hexsel et al. (2017) was open-label and single-centre with 25 participants on 2.5 g/day for 24 weeks; endpoints were physician-assessed nail growth rate, frequency of cracked or chipped nails and a global improvement score, and two authors were affiliated with the manufacturer’s Collagen Research Institute. Proksch et al. (2014) randomised 69 women aged 35-55 to 2.5 g, 5.0 g or placebo for 8 weeks; skin elasticity, the primary outcome, was significantly higher than placebo in both active groups at 8 weeks, while moisture and transepidermal water loss did not reach significance; no side effects were noted.
Beer et al. (2014) randomised 50 women to two daily capsules containing 500 mg solubilised keratin from New Zealand sheep wool plus vitamins and minerals, or maltodextrin, for 90 days (EudraCT 2014-002645-22) and reported statistically significant improvements in hair loss, growth, strength, lustre and nail strength; two authors were from the ingredient’s commercial suppliers, and the multi-ingredient active arm cannot attribute effects to keratin. All evidence is oral. Neither collagen hydrolysate nor keratin appears on FDA’s 503A category lists, and no data on injected use for cosmetic endpoints were found.
Why researchers might study these together
The idea behind the blend is simple. Hair and nails are made of keratin, and skin is held up by collagen. Making those proteins takes amino acids and helper vitamins. So, the thinking goes, supplying the helpers and the building blocks should give better hair, skin and nails. This is a hypothesis, not a result.
The problem is that deficiency logic does not transfer to people who are not deficient. Biotin fixes hair loss caused by biotin deficiency. That does not mean extra biotin grows hair in someone with normal levels. The same applies to the other vitamins. The body gets rid of extra water-soluble vitamins in the urine. No study has tested the mixture. No study has compared oral with injected use. The one trial with a placebo and a clear result, the 2014 collagen skin study, used collagen alone, by mouth.
The rationale is nutritional: keratinocyte and fibroblast protein synthesis depend on amino-acid supply and on B-vitamin coenzymes, and biotin, folate and niacin deficiencies produce recognisable hair, skin and nail changes. The blend supplies cofactors and, in some versions, collagen- or keratin-derived peptides as substrate. Two assumptions are untested. First, that supra-physiological cofactor supply increases the rate of keratin or collagen synthesis in replete individuals; the saturable absorption and renal excretion of thiamine, riboflavin and biotin argue against sustained elevation. Second, that orally studied collagen peptides retain any effect when the mixture is injected, which has not been examined.
No preclinical or clinical study of the combination, or of any pair of its components for cosmetic endpoints, was identified. The controlled human data are confined to single ingredients given orally: Proksch et al. (2014) for collagen hydrolysate and Beer et al. (2014) for a keratin-vitamin-mineral capsule. Whether the B-vitamin, choline and inositol components add anything to those ingredients, or to nothing, has never been tested.
Regulatory picture
Approval: no regulator has approved a product with this combination, for hair, skin, nails or anything else. Taken by mouth, these ingredients are sold in the United States as dietary supplements. Supplements fall under food rules, not drug rules, and their claims are not reviewed before sale. An injection is a drug. An approved B-vitamin injection, Infuvite Adult, exists, but only for people fed through a vein.
Compounding (pharmacies mixing their own drugs): the FDA judges each ingredient on its own. Thiamine, riboflavin, niacinamide, folic acid and biotin are parts of approved injections, so pharmacies may use them. Inositol has an official monograph, which also qualifies it. Choline chloride is “under evaluation” (Category 1). Pantothenic acid was nominated without enough support (Category 3). Collagen and keratin have not been nominated at all. The blend as a whole has no status of its own.
Enforcement: the FDA has not, as far as we found, acted against this blend by name. In January 2026 it wrote to an outsourcing facility whose injectable B-complex held less than half the labelled pantothenol. The FDA also warns that biotin can distort lab tests.
Approval: none. Orally, the components are marketed as dietary supplements under DSHEA; no supplement claim for hair, skin or nail benefit has been evaluated by FDA. Parenterally, the only approved precedent is Infuvite Adult, indicated for prevention of vitamin deficiency in parenteral nutrition.
Compounding: under section 503A(b)(1)(A)(i) of the FD&C Act, each bulk drug substance must comply with a USP or NF monograph, be a component of an FDA-approved drug, or appear on the 503A bulks list (21 CFR 216.23). Thiamine, riboflavin, niacinamide, dexpanthenol, folic acid and biotin are components of the approved Infuvite Adult; myo-inositol has an NF monograph; choline chloride is in 503A Category 1 (under evaluation, with enforcement discretion under FDA’s interim policy) on the list updated 2026-05-14; pantothenic acid and choline bitartrate are in Category 3; collagen hydrolysate and keratin are not nominated. A blend has no status of its own and inherits the least-established status of its ingredients, so this article records compounding as unknown.
Enforcement: no FDA action naming this blend was found. FDA’s 2026-01-20 warning letter to GenoGenix LLC, an outsourcing facility, cited an “Injectable B Complex” containing 43.1% of labelled dexpanthenol and a methylcobalamin injection at 65.3% of label, illustrating the content variability of unapproved injectable vitamin products. FDA’s biotin interference page (2022) lists troponin assays still subject to interference and reports continuing adverse-event reports of falsely low results.
