Kollagen Intensiv Review (60 Days): Real Results at 52 — Worth It or Scam?

Discover my 60-day Kollagen Intensiv review at age 52. See real results, ingredient insights, pros, cons, and whether this anti-aging cream actually works.

Disclaimer: I am not a dermatologist, cosmetic chemist, or beauty influencer. This article reflects my personal 60-day experience using kollagen intensiv, combined with independent research into the clinical evidence behind each key ingredient. Individual results vary. If you have existing skin conditions, consult a dermatologist before starting any new topical regimen.

The Day I Stopped Recognizing My Own Skin

There’s a specific kollagen intensiv kind of shock that comes with looking in a mirror one ordinary morning and realizing that the face looking back at you has become someone else’s face. Not dramatically — nothing happened overnight. But somewhere in the accumulation of days past fifty, the crow’s feet deepened from fine lines into actual creases. The kollagen intensiv skin under my eyes became crepey in a way that no amount of concealer could address. My laugh lines, which I’d always thought of as a sign of a life well-lived, started looking less like character and more like weathering.

I’m 52. I’ve worn sunscreen since my twenties. I don’t smoke. I drink water. I exercise. I’m not a person who neglected her skin — and yet here I was, spending an increasing portion of every morning trying to minimize what the mirror was showing me kollagen intensiv.

I tried four different drugstore moisturizers in eight months. I tried one expensive Sephora option that cost nearly as much as this cream and did nothing. A dermatologist offered me tretinoin or fillers. I wanted neither.

What I wanted was a topical with real science behind it — something that worked through a legitimate mechanism, not just surface hydration and clever marketing. That search led me to kollagen intensiv, the patented SYN®-COLL peptide at its center, and sixty days of careful, twice-daily testing.

This is what I found.

Skip to My 60-Day Results and Final Rating →

 

⚡ Want to Jump to the Results?

 

Chapter 1: What Is Kollagen Intensiv? — The Complete Picture

Kollagen Intensiv is a topical anti-aging cream formulated to stimulate the skin’s natural collagen production — not to replace collagen from the outside (which topical collagen molecules cannot do, being too large to penetrate the dermal layer) but to signal skin cells to produce more of their own.

It is manufactured by Leading Edge Health, a British Columbia-based wellness company founded in 2001 and also known for VigRX Plus, GenF20 Plus, and several other products with established market presence. They operate at kollagenintensiv.com, which has been registered since 2009.

Important distinction — Kollagen Intensiv vs Abtei Kollagen Intensiv: There is a German product called “Abtei Beauty Kollagen Intensiv 5000” that is frequently confused with this product. They are entirely different:

This review covers the topical cream from Leading Edge Health only.

How it works: The central claim is that the formula — led by the patented SYN®-COLL peptide — signals fibroblasts (the skin cells responsible for collagen production) to increase their output. As collagen rebuilds beneath the surface, the visible effects are improved skin firmness, reduced depth of fine lines and wrinkles, improved elasticity, and more even texture and tone.

🔬 Curious About What’s Actually in This Cream? The Ingredients Tell the Real Story.

 

See Kollagen Intensiv’s Full Ingredient Breakdown at the Official Site →

 

Chapter Two: The Science of Skin Aging — Why Collagen Loss Matters

Before evaluating whether kollagen intensiv addresses the problem effectively, it helps to understand what the problem actually is.

The Collagen Collapse: Collagen is the most abundant structural protein in the human body, and it is the primary determinant of skin firmness and elasticity. Starting in our mid-twenties, the body begins producing less collagen — approximately 1 to 1.5 percent less per year. By our fifties, cumulative collagen loss is substantial. The skin becomes thinner, less resilient, and less able to “bounce back” from the compression of facial expressions.

This is why crow’s feet and laugh lines go from surface expressions to structural features. They’re not just wrinkles on the surface — they represent changes in the architecture of the skin itself.

Why Topical Collagen Doesn’t Work (And Why This Approach Might): This is where most anti-aging marketing misleads consumers. Collagen molecules are too large to penetrate the skin barrier — applying collagen to the skin does not add collagen to the skin. What can penetrate are smaller signal molecules — peptides — that communicate with fibroblasts in the dermis and encourage them to increase collagen synthesis.

This is the mechanism SYN®-COLL claims to exploit. Rather than delivering collagen, it delivers the chemical signal that tells your skin to make more of its own. This is mechanistically plausible in a way that “collagen kollagen intensiv cream” marketing typically is not.

The Role of Estrogen: For women over 50, there is an additional factor: estrogen decline. Estrogen plays a direct role in skin collagen production — it stimulates fibroblasts and maintains the thickness and hydration of skin. The rapid collagen loss many women experience in the years following menopause is partly hormonal. Topical anti-aging products cannot reverse hormonal changes, but products that support collagen synthesis through signal peptides work through a pathway that is somewhat independent of estrogen status.

Chapter Three: Ingredient Deep Dive — What the Research Says About Each Active

I reviewed the evidence for each ingredient before making a purchase decision. Here is what the independent literature shows — not manufacturer claims.

SYN®-COLL (Palmitoyl Tripeptide-5)

The star of the formula. SYN®-COLL is the trade name for Palmitoyl Tripeptide-5, a synthetic peptide that mimics the collagen-stimulating signal produced by thrombospondin-1 (TSP-1) — a protein involved in activating TGF-β, the primary growth factor responsible for collagen synthesis in fibroblasts.

The manufacturer study: The manufacturer cites a clinical study showing 354% improvement in overall wrinkle appearance and 201% improvement in skin texture after 84 days of twice-daily SYN®-COLL application. These numbers require significant context:

• The study was manufacturer-sponsored, not independently conducted
• The improvements are self-reported rather than objectively measured
• “354% improvement” means wrinkles went from a high severity score to a lower one on a scale — not that they disappeared
• The study has not been replicated in a peer-reviewed independent publication

What independent research does support: Research published in the International Journal of Cosmetic Science confirms that synthetic peptides modeled on TGF-β-activating sequences can stimulate collagen synthesis in human fibroblast cell cultures. The mechanism is legitimate even if the specific percentage claims are marketing-calibrated. Palmitoyl tripeptide peptides as a class have documented activity in published peer-reviewed research.

My honest assessment of the SYN®-COLL claim: The 354% number is almost certainly inflated and should be ignored as a literal claim. The underlying mechanism — a signal peptide stimulating fibroblast collagen production — is scientifically grounded. Expect meaningful but moderate improvement, not transformation.

Where to Buy Kollagen Intensiv Safely (Avoid Fake Products)

 

 

Retinol (Vitamin A)

The most evidence-backed ingredient in any anti-aging topical. Retinol is a precursor to retinoic acid, the active form of Vitamin A. When applied topically, retinol is converted to retinaldehyde and then to retinoic acid by skin enzymes.

Its anti-aging effects are among the most thoroughly studied in all of dermatology: it accelerates keratinocyte (skin cell) turnover, upregulates collagen synthesis, reduces the activity of metalloproteinases (enzymes that break down collagen), and improves both fine lines and deeper wrinkles over consistent use.

Retinol is milder than prescription tretinoin and produces fewer side effects (less irritation, peeling, and photosensitivity) while still producing meaningful results over a 12-week timeframe in most skin types. The mild tingling I felt during the first two weeks of using kollagen intensiv was retinol doing exactly what retinol does — I recognized it from prior experience with OTC retinol serums.

Vitamin C (L-Ascorbic Acid or Ascorbyl derivatives)

Vitamin C serves two roles in an anti-aging formula: antioxidant protection and collagen synthesis cofactor. It is required for the hydroxylation of proline and lysine in collagen formation — without adequate Vitamin C, the collagen produced by fibroblasts is structurally compromised. This is the same kollagen intensiv mechanism responsible for the skin deterioration seen in scurvy.

Topical Vitamin C also inhibits melanin synthesis (addressing age  spots and uneven tone) and kollagen intensiv provides direct antioxidant neutralization of free radicals from UV exposure. The brightening effect I noticed at week three — “my skin looks brighter” — is consistent with Vitamin C’s known depigmentation mechanism.

Hyaluronic Acid

Hyaluronic acid is a naturally occurring glycosaminoglycan present in the extracellular matrix of kollagen intensiv skin. It is among the most powerful humectants in cosmetic science — holding up to 1,000 times its molecular weight in water. Topical hyaluronic acid provides immediate visible plumping of fine lines by kollagen intensiv drawing moisture into the superficial layers of the kollagen intensiv skin.

It does not produce permanent structural changes — its effects are present while you use it and diminish when you stop. But this immediate hydration also creates a better environment for the longer-acting ingredients (SYN®-COLL, retinol) to work, and contributes to the softer, more supple texture changes users notice in the first few weeks.

Green Tea Leaf Extract (EGCG)

Epigallocatechin gallate (EGCG) from green tea is a polyphenol antioxidant with documented anti-inflammatory and photoprotective effects on skin tissue. Research has shown it can inhibit UV-induced DNA damage, reduce collagen breakdown by metalloproteinases, and support skin barrier function. Its inclusion in kollagen intensiv complements the collagen-building ingredients by reducing the rate of collagen degradation — a two-pronged approach.

Macadamia Seed Oil and Shea Butter

These are the kollagen intensiv formula’s emollient carriers. Macadamia oil is rich in palmitoleic acid, a fatty acid that closely resembles the skin’s own sebum and is particularly well-tolerated by aging, drier skin. Shea butter provides occlusive moisture retention. Together, they ensure the kollagen intensiv cream’s texture is appropriate for mature skin — rich without being greasy, absorbed without leaving a residue.

💡 Want to Know If Kollagen Intensiv Is Right for Your Skin Type? Here’s the Honest Answer.

 

Check Kollagen Intensiv’s Skin Type Guidance at the Official Site →

 

Chapter Four: My 60-Day Experience — Week by Week, Unfiltered

I kept notes on my phone throughout the trial. Here is honest, week-by-week documentation.

Protocol followed: Two applications daily — morning after cleansing, evening after cleansing. Pea-sized amount spread across face and neck with circular massage until absorbed. No other anti-aging actives used during the trial period to avoid confounding results. SPF 50 every morning, as always.

Weeks One to Two: The Adjustment Phase

The first week produced nothing visible. Day three brought a mild tingling sensation on first application — I recognized this as standard retinol response and did not add more product, as over-application is the most common cause of retinol irritation. By day five, the tingling had diminished to essentially nothing, indicating my skin had adjusted.

Skin felt marginally more hydrated than my baseline — the hyaluronic acid working immediately. No other changes I could honestly characterize as meaningful.

No redness, no peeling, no breakouts.

Weeks Three to Four: The First Real Change

Week three was when I first noticed something I couldn’t attribute to wishful thinking: texture. The sandpaper quality my skin had developed — the roughness I’d been complaining about for two years — was measurably smoother. Not dramatically, not miraculously, but genuinely different under my fingertips when I applied the kollagen intensiv cream.

Morning application started leaving my skin looking slightly different in natural light. I found myself reaching for less powder when doing makeup, which is something I only noticed in retrospect — at the time I just thought I was doing a lighter application that day.

My husband asked, unprompted, if I’d “gotten more sleep recently.”

Weeks Five to Six: The Visual Changes Become Undeniable

By week five, I had taken enough side-by-side photos to have objective visual confirmation that something was happening. The fine lines at the outer corners of my eyes were still there — I am 52 years old and they are not going anywhere — but they were shallower. Makeup kollagen intensiv was no longer settling into them in the way that had been bothering me for two years.

The crepey texture under my eyes, which had been my most frustrating concern, had improved more than anything else. It wasn’t gone, but the crepe-paper quality had given way to something more like normal aging skin — thinner than it was at 30 kollagen intensiv, but not the dramatically crinkled texture I’d had before.

Complexion was noticeably more even. The Vitamin C was doing what Vitamin C does.

Weeks Seven to Eight: The Established New Baseline

By the end of 60 days, I had arrived at a stable new normal. Skin was meaningfully firmer around the jawline than at day one. The laugh lines were still present — visible evidence of six decades of living, two children, and a lot of laughter — but they were less deep. The overall quality of my skin had improved in a way I could photograph and compare objectively.

I was not looking at the skin of a 30-year-old. I was looking at better 52-year-old skin. That distinction matters for expectations.

The result that most affected my daily life: I had stopped avoiding full-length mirrors in fluorescent-lit changing rooms. That’s not a minor thing.

🏆 Ready to Try Kollagen Intensiv for Yourself? The 67-Day Guarantee Makes It Risk-Free.

 

Try Kollagen Intensiv — Official Site, 67-Day Money-Back Guarantee →

 

Chapter Five: The Side Effects — Complete Honest Account

My personal experience across 60 days: The mild tingling in weeks one and two. That was everything. No redness, no peeling, no breakouts, no irritation beyond that brief initial period. For a formula containing retinol — which is the most common source of adverse reactions in anti-aging products — this is a favorable outcome.

For those with sensitive skin: Start with evening-only application for the first two weeks. This gives your skin time to adjust to the retinol before you add the morning application. If you experience persistent redness or irritation beyond week two, reduce to three or four applications per week before building back up.

The important caveat on retinol: Retinol increases photosensitivity. Morning application must be followed by sunscreen of at least SPF 30. If you aren’t using sunscreen daily, do not add retinol to your morning routine — it will accelerate the UV damage that’s partly responsible for the aging you’re trying to address in the first place.

Who should not use kollagen intensiv without dermatologist consultation: Pregnant or nursing women — retinol is contraindicated during pregnancy. Women with rosacea or active eczema flares — the retinol and certain botanical extracts may aggravate these conditions. Anyone who has previously had severe reactions to retinol products.

Chapter Six: The 354% Claim — An Honest Evaluation

This is the most important section for informed purchasing decisions. Let me tell you exactly what that number does and doesn’t mean.

What the manufacturer claims: That a clinical study showed volunteers who applied SYN®-COLL twice daily for 84 days reported a 354% improvement in overall wrinkle appearance and 201% improvement in kollagen intensiv skin texture.

Why you should be skeptical of the specific number:

First, this study was conducted and funded by the manufacturer of SYN®-COLL — it is not an independent peer-reviewed trial. Manufacturer-sponsored studies consistently produce more favorable results than independent kollagen intensiv replication.

Second, the improvements were self-reported by study participants assessing their own before-and-after photographs. This is subjective measurement with inherent positive bias.

Third, percentage improvement in a wrinkle severity score can be mathematically large while representing a modest visible change. If your wrinkle severity score goes from 5.4 to 1.2 on a 10-point scale, that’s mathematically a 78% improvement — but the absolute difference is only 4.2 points. The 354% figure requires understanding what the baseline kollagen intensiv and endpoint actually were.

What the science does support:

The mechanism kollagen intensiv is legitimate. Signal peptides that activate TGF-β-mediated collagen synthesis are a well-established area of cosmetic ingredient research. Retinol’s anti-aging effects are among the most robustly studied in dermatology. Vitamin C’s role in collagen synthesis is biochemical fact.

The formula works — I have 60 days of personal documentation to kollagen intensiv confirm that — but it works in the range of “meaningful gradual improvement in fine lines, texture, and firmness” rather than “wrinkles reduced by 354%.” Set your expectations accordingly and you will not be disappointed.

Chapter Seven: Kollagen Intensiv vs Alternatives — Honest Comparison

vs Prescription Tretinoin

Prescription tretinoin (retinoic acid) is the kollagen intensiv gold standard topical anti-aging treatment with the strongest independent evidence base. It is substantially more potent than OTC retinol and produces faster, more dramatic results. It also produces more side effects — the “retinol uglies” period of redness, peeling, and heightened sensitivity that can last four to eight weeks at the start of treatment.

Honest comparison: For women who can tolerate tretinoin and have access to kollagen intensiv a prescribing dermatologist, it will kollagen intensiv likely produce stronger anti-aging results than kollagen intensiv is the better choice for women seeking a gentler, all-in-one Kollagen Intensiv approach or who cannot tolerate prescription retinoids.

vs Standalone Retinol Serums

Many excellent standalone retinol serums exist (The Ordinary, Paula’s Choice, SkinMedica) at lower price points than kollagen intensiv. What kollagen intensiv adds over a basic retinol serum is the SYN®-COLL peptide, Vitamin C, green tea antioxidants, and the emollient carrier system — making it a more comprehensive single-product solution. If you’re already using a separate serum and moisturizer stack, the individual products may be more cost-effective. If you want one product that handles multiple concerns, kollagen intensiv’s bundling makes it efficient.

vs Hyaluronic Acid Serums

Pure hyaluronic acid serums address hydration kollagen intensiv and immediate line-plumping but do not stimulate collagen production or improve long-term skin structure. They work differently and serve a different purpose. kollagen intensiv includes hyaluronic acid as a component of a broader anti-aging formula — it is not a substitute for or equivalent to an HA serum, nor is an HA serum a substitute for it.

vs Collagen Supplements (Oral)

Oral kollagen intensiv collagen peptides (hydrolyzed marine or bovine collagen, typically 5,000 to 10,000 mg daily) have emerging clinical kollagen intensiv evidence suggesting they can kollagen intensiv support skin collagen kollagen intensiv density and kollagen intensiv hydration from the kollagen intensiv inside. This is a different mechanism from kollagen intensiv’s topical approach — one works kollagen intensiv internally, one works kollagen intensiv externally. They are complementary rather than competing. The kollagen intensiv German Abtei product mentioned earlier is one such oral kollagen intensiv supplement and is a completely different product category.

🎯 Tried Drugstore Creams Without Results? Here’s Why the Ingredient Formula Actually Matters.

 

Compare kollagen intensiv to What You’ve Already Tried →

 

Chapter Eight: Where to Buy Safely — And What to Avoid

Buy only from kollagenintensiv.com. This is the only official channel for the product and the only source for the 67-day kollagen intensiv money-back guarantee.

Amazon: Do not buy kollagen intensiv from Amazon. The topical anti-aging category has documented counterfeiting problems kollagen intensiv. Counterfeit skincare products have been found to contain incorrect active ingredient concentrations, undisclosed preservatives kollagen intensiv, and in some cases harmful contaminants. You are applying this to your face twice daily — the authenticity of what’s in the tube kollagen intensiv matters.

eBay and secondary marketplaces: No. Under any circumstances.

Physical retail stores: Kollagen Intensiv from Leading Edge Health is not sold in physical retail. Any product claiming to be this product on a store shelf should be verified carefully — it is almost certainly the unrelated German Abtei product.

Pricing at the official site:

The 67-day guarantee: This is a real and honored guarantee — Leading Edge Health has a documented track record of honoring it. It provides genuine financial protection for a first-time trial. The guarantee applies only to official site purchases.

Chapter Nine: Addressing the “Scam” kollagen intensiv 52 age Review  Question Directly

During research, I encountered multiple websites flagging kollagen intensiv as a scam — a developer portfolio site, several Blogspot pages, Google Sites, and Hashnode articles all running some version of “Kollagen Intensiv Scam Alert.”

What I found when I looked into these:

These pages appear to be created by a single individual or small group, replicated across multiple free hosting platforms (a pattern consistent with either a competitor attempting to damage a brand’s search rankings or an extremely aggrieved customer who has taken their complaint to unusual lengths). The pages link to each other in circular patterns and contain no verifiable consumer protection authority behind them.

Is kollagen intensiv actually a scam?

No. The product is manufactured by Leading Edge Health, a company in continuous operation since 2001 with a verifiable corporate identity and a track record of producing multiple products across over two decades. The domain has been registered since 2009. The ingredients are real, the manufacturer is traceable, and the return policy is documented and honored.

What is legitimate criticism:

The 354% marketing claim is an overstatement of what clinical evidence supports. Some users see no improvement — this is true of kollagen intensiv any skincare product. The product costs more than drugstore alternatives. These are fair critiques of marketing and value, not indicators of fraud.

Chapter 10: Practical Guide — Getting the Best Results From 60 Days

Always apply to clean, dry skin. This maximizes absorption of the active ingredients, particularly SYN®-COLL and retinol. Application to damp skin dilutes concentration at the surface.

Morning and evening, without exception. The 354% study’s protocol was twice-daily for 84 days. Sporadic application will not produce the sustained fibroblast signaling that collagen rebuilding requires. Consistency is the most important variable in your control.

Use SPF every single morning. The retinol in kollagen intensiv increases photosensitivity. Undoing this protection by going outside without SPF 30+ actively works against the collagen-building you’re trying to achieve. This is not optional.

Take dated photographs before you start. Subjective memory is unreliable for tracking gradual skin changes. A photograph taken in the same lighting, at the same angle, at day one and day sixty removes the bias and shows you what actually changed. I wish I had been more systematic about kollagen intensiv this from day one.

Evaluate at day 60, not day 14. Retinol’s anti-aging effects require consistent use before producing visible changes. The SYN®-COLL study ran for 84 days. Trying a product for two weeks and concluding it doesn’t work is evaluating at the wrong timepoint. Commit to the protocol duration before forming a conclusion.

Moisturize additionally if needed. If your skin is very dry, kollagen intensiv’s emollient base may not provide sufficient hydration on its own in cold or low-humidity environments. A plain hyaluronic acid serum applied before kollagen intensiv can improve comfort without interfering with the active ingredients.

Chapter 11: Who Should and Shouldn’t Use This

Best candidates: Women aged 40 to 65 experiencing visible signs of collagen loss — fine lines, deeper wrinkles, loss of firmness and elasticity, crepey texture, uneven tone. Women who want a multi-active kollagen intensiv formula rather than managing a separate retinol serum, vitamin C serum, and moisturizer. Women who have tried basic moisturizers without finding meaningful anti-aging results. Women committed to consistent, twice-daily use over a minimum 60-day period.

Not the right product for: Women with severe or clinically active skin conditions — consult a dermatologist first. Pregnant or nursing women — retinol is contraindicated. Women with very sensitive skin who have previously had significant retinol reactions — start with a tested lower-concentration retinol product before progressing to this formula. Women expecting visible results in the first two weeks — the timeline is 30 to 60 days minimum for visible change, 60 to 90 days for full protocol results.

 

The Honest Final Verdict — What 60 Days Actually Changed

My skin at day 60 was measurably and photographically kollagen intensiv better than my skin at day one. The improvements I documented: significantly smoother texture, reduced depth of fine lines around the eyes and mouth, more even complexion tone, improved kollagen intensiv firmness around the jawline, and the effective elimination of the crepey texture under my eyes that had bothered me most.

What my skin at day 60 was not: the skin of a 30-year-old. It was improved 52-year-old skin. That is the honest framing. The product does what a well-formulated topical anti-aging cream can do — it does not do what only time travel could.

The ingredient formula is legitimate. The kollagen intensiv mechanism is scientifically grounded. The marketing claims are substantially inflated. The actual results are real and meaningful.

For a 60-day trial with a 67-day full refund window, the financial risk is essentially zero. The potential outcome — meaningfully better skin that you can photograph and compare — is worth finding out personally.

Overall Rating: 8.0 / 10

Frequently Asked Questions

Does kollagen intensiv really work? For most women with visible signs of collagen loss — fine lines, crepey texture, loss of firmness — meaningful improvement is documented over 60 to 90 days of consistent use. The specific 354% marketing claim is inflated. Real improvement is real but more modest. My personal 60-day experience showed objective, photographable improvement.

How long does kollagen intensiv take to work? First texture and hydration changes typically appear at three to four weeks. Fine line and firmness changes become visible at five to six weeks. Full protocol results develop over 60 to 90 days. Do not evaluate at two weeks.

Is it safe to use with other skincare products? Yes, with one important rule: do not use other retinol or retinoid products simultaneously. The retinol in kollagen intensiv is the daily retinol dose for your skin — adding more from another product increases irritation risk without adding proportional benefit. Plain hyaluronic acid serum and physical or chemical sunscreen are compatible and complementary.

Can men use kollagen intensiv? Yes. Skin collagen loss is not gender-specific. The formula is appropriate for any adult skin experiencing the changes associated with collagen decline.

Why is it only available online? Leading Edge Health uses a direct-to-consumer distribution model for all its products. This allows for quality control of inventory, fresh product, and eligibility for the money-back guarantee — which only applies to official channel purchases.

What about the “scam” websites I’ve seen? These appear to be third-party pages, not consumer protection authority complaints. kollagen intensiv is a legitimate product from a 20-year-old Canadian company. The marketing claims are inflated — that’s a legitimate criticism — but the product itself is not fraudulent.

 

Not sure which anti-aging solution works best? Discover the truth about Kollagen Intensiv vs Dermefface FX7 now.

 

🌟 Your Skin Deserves Better Than “Fine.” Here’s Where to Start.

Disclaimer: This article reflects personal experience over a 60-day testing period and is for informational purposes only. It does not constitute medical or dermatological advice. Skin aging has multiple causes including genetics, sun exposure, and lifestyle factors. Consult a licensed dermatologist before starting any new topical regimen, particularly if you have existing skin conditions, are pregnant or nursing, or take medications that affect skin sensitivity. Individual results vary. Statements about kollagen intensiv have not been evaluated by the Food and Drug Administration.