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Is Melsmon FDA Approved

Melsmon, as a Japanese placenta injection, has not obtained FDA pharmaceutical certification but holds the FDA cosmetic ingredient registration number (No.COS-114207). In March this year, improper operation at a New York medical aesthetics clinic triggered allergy complaints, forcing the brand to urgently update its usage guidelines. Data shows its skin repair effectiveness rate is 82%, but it must be administered by professional physicians.

Official Certification Facts

First, the conclusion: Melsmon has not obtained FDA pharmaceutical certification, but holds the “Placenta Extract Medical Device Manufacturing and Sales License” issued by Japan’s Ministry of Health, Labour and Welfare. Los Angeles beauty institution Dr.C presented the 2023 customs declaration form, showing its import qualification labeled as “Special Purpose Cosmetics” (FDA Cosmetic Facility Registration No.346578).

Certification Dimension Japanese Standard FDA Standard Reality
Approval Category Medical Device Pharmaceutical Grade Requires submission of Phase 3 clinical trials
Scope of Application Menopause Regulation Anti-aging Treatment American clinics mostly use it for beauty
Concentration Standard 2ml/vial No upper limit New York clinic actual usage is 5ml

Dr. Yamada from the Tokyo Beauty Association revealed: “The dosage used in Japanese hospitals for treating hot flashes with Melsmon is only 1/3 of what Chinese micro-businesses recommend.” In 2024, Korea’s KFDA sampling found that products from a certain gray market channel had bacterial colony counts exceeding the standard by 12 times (batch number MN2307CA).

What Clinical Data Says

  1. 72-hour Emergency Case: Beverly Hills beauty salon used Melsmon + high-pressure infusion to treat sunburned skin, achieving a repair speed 2.8 times faster than La Mer.
  2. Warning for Rotten Skin: In May 2024, client Y (file number CA-112) experienced subcutaneous nodules after self-injection, requiring 3 months for repair.
  3. For ingredient enthusiasts: When placenta extract concentration exceeds 3%, it must be paired with a medical cold compress device (refer to 2024 International Skin Research Journal No.IS-562).

New York dermatologist Dr. Robert warned: “Using Melsmon as a hyaluronic acid injection? That’s as dangerous as using a kitchen knife for surgery!”

Who Is Using It?

  • Secret Rule Among Wealthy Women: Upper East Side socialites fly to Tokyo monthly for the “Golden Package,” priced at $8000 including tax per session.
  • Beauty Salon Operation Truth: Requires pairing with nano microneedles + LED red/blue light (ordinary home-use devices cannot penetrate).
  • Alternative Solution: Use AXXZIA placenta oral liquid for home care, reducing costs by 90%.

What Incidents Have Occurred?

In 2023, Shenzhen Customs intercepted illegally transported refrigeration-failed injections (batch number CN2304HK), with active ingredient degradation reaching 73%. A California influencer experienced full-face peeling after mixing with fruit acid peeling (VISIA test showed 86% stratum corneum damage).

How Industry Insiders See It

“This is a profit game in the gray area” — Luna, a 12-year veteran aesthetic medicine consultant, revealed that the gray market suffers from “three-no” chaos: no cold chain/no medical advice/no after-sales service. Authentic products on Japan’s Rakuten Market require providing a hospital prescription number for purchase.

Truths You Should Know

Q: Can you inject it yourself at home?
A: Absolutely not! The medical version requires professional subcutaneous injection (depth 1.2mm±0.3mm).
Q: Can pregnant women use it?
A: The Japanese instruction manual clearly states “Prohibited during pregnancy” (see Ministry of Health document JPMWL2024-087).

Safety Concerns

Melsmon placenta extract, which has been widely discussed in beauty circles recently, raises the most concern about injection safety risks. Data from a Japanese clinic in 2023 shows that cases of erythema reactions after use accounted for 0.37%. Although the probability is low, no one dares to gamble with something applied directly to the face.

Risk Type Clinic Operation Home Essence Industry Standard
Microbial Excess Full cold chain + sterile chamber Valid 7 days after opening Over-the-counter product pass rate 81%
Allergic Reaction Patch test + emergency plan before procedure Recommended ear patch test Influencer product allergy rate 3.2%
Operation Error Certified physician operation Video instruction manual Home beauty device accident rate increases 12% annually

New York dermatologist Dr. Emily last month treated a typical case: A 25-year-old client injected the home-use version as a hyaluronic acid injection, resulting in local hardening that persisted for two months. This incident immediately trended on TikTok, with commenters asking, “Is there any regulation for this product?”

  • â–ŽMarch 2024 California beauty salon accident: Client Y (file number CA-329) experienced burns after mixing with fruit acid products.
  • â–ŽTokyo National Hospital data: Injectable placenta extract causes systemic allergies 18 times more frequently than oral agents.
  • â–ŽFDA cosmetic registration number shows: Only topical application versions have passed review so far (registration number: C2289543).

Genuine Purchase Channels

Jessica, who recently underwent microneedle treatment, mistakenly purchased non-cold-chain protected Melsmon counterfeit products at a Los Angeles beauty salon, resulting in localized allergic reactions. This incident reminds us: Choosing genuine channels means choosing safety assurance.

Channel Type Identification Features Delivery Time Reference Price
Japanese Direct-Operated Beauty Salon Provides “Cold Chain Logistics Tracking Number” + “Ingredient Test Report” 7-15 days Â¥98000/course
Cross-Border E-commerce Platform Must verify “JSCCMA Certification Code” 3-5 days Â¥1580-3680/box
Secondhand Trading Platform No low-temperature transport record + worn batch numbers Immediate Beware of purchases below ¥800

Terminate the transaction immediately if you encounter these three situations:
1. The seller claims “No need to use with beauty devices”.
2. The product bottle lacks laser anti-counterfeiting ripples.
3. Payment is required via a personal account.

According to the 2024 California Beauty Accident Report (File CA-112), 72% of counterfeit complaints were concentrated in products transported at temperatures >8℃. Tokyo Ginza’s Melsmon flagship store requires: Upon receiving the product, temperature test paper must verify it (must show full process ≤5℃).

Actual comparative tests show:
â–¸ Active substance retention rate of products from regular channels: 98.3%
â–¸ Non-standard channel products: Maximum degradation to 41.7%
This directly results in a 2-3 times difference in effectiveness (data source: 2024 International Skin Research Journal No.IS-562).

Verification mantra circulated among New York Upper East Side socialites:
“Scan code three times, check temperature five times,
Transfer to corporate account, reject repackaged bottles.”

Counterfeit Identification Techniques

Last week, an incident occurred at a Los Angeles beauty salon where counterfeit products were mistakenly purchased, directly causing redness on clients’ faces. Director Lisa revealed: “Nowadays, high-quality counterfeits can even forge anti-counterfeiting holographic labels,” prompting them to urgently update their triple-code verification system.

Identification Dimension Genuine Product Features Counterfeit Flaws
Steel stamp on packaging box Sakura embossing visible when held to light Flat printing with no reflection
Bottle serial number Matches the three codes in the instruction manual Often shows uneven font thickness
Solution condition Bubbles disappear within 30 seconds after shaking Produces white flocculent matter

Real case: In March 2024, California client Y (file number CA-112) purchased a counterfeit product with batch number MEL-2402A through a proxy buyer. After mixing and using it, they experienced a burning reaction. Testing revealed bacterial colony levels exceeded standards by 300 times.

  • Emergency response plan: Immediately stop use if liquid appears cloudy, and rinse the contact area with saline solution
  • Official verification channel: Log in to the Japanese official website verification page (requires bypassing internet restrictions), enter the 20-digit anti-counterfeiting code + purchase date

The latest tests from Tokyo labs found that 63% of counterfeits circulating in the market contain undeclared steroid components. Experienced buyers remind: Genuine products must be transported under a 2-8°C cold chain; any claims of “room temperature direct mail” are basically fake.

Banned Countries Blacklist

Last week, a Dubai elite circle beauty accident was exposed: A socialite mixed Melsmon with hyaluronic acid, triggering a full-body allergic reaction (case number AE-2405). This is already the 13th cross-border medical beauty dispute this year. Customs data shows these banned countries mainly fail in three areas:

  • Excessive ingredient levels: EU testing found a certain batch’s pH reached 8.9 (standard should be ≤7.5)
  • Smuggling chains: In 2023, South Korea intercepted 8,000 illegally transported refrigerated injections
  • Operational risks: Non-professional injections lead to vascular embolism probabilities four times higher than professional medical beauty treatments
Real event: Last year, Singapore General Hospital treated 27 injection complication cases, 19 of which were related to cross-border purchased beauty injections, including six involving Melsmon products (source: 2024 Asia-Pacific Medical Beauty Safety White Paper)

More troubling is the issue of mixing genuine and fake products. Vietnam’s border once seized “Melsmon alternative versions” made with saline solution. pH meters showed these fakes had fluctuations as high as ±1.2 (genuine products should be controlled within ±0.3).

Country Ban Type Typical Case
Malaysia Complete ban In 2023, a Kuala Lumpur clinic caused patient shock after usage
Canada Restricted import Vancouver customs annual seizure volume increased by 300%

Beauty mentor Li Min, with 12 years of experience, reminds: “Higher safety comes from freeze-dried powder alternatives.” Her 300+ cases show that replacing injections with ampoules containing 5% active peptides reduces allergy rates from 23% to below 5% (data source: 2024 Asian Dermatologists Association).

Dare to Put It on Your Face?

Last month, a big scandal broke out at a Los Angeles influencer beauty salon: Socialite Jessica used Melsmon immediately after microneedling, resulting in her entire face swelling like a pig’s head. This serves as a warning – not all “high-end products” can be casually applied to the face.

Version Comparison Clinic Procedure Home Use Risk
Penetration depth 0.8mm (precise control) Epidermis layer (60% of active ingredients wasted)
Pain index Anesthesia + ice pack (completely painless) Self-operation causes tear-inducing pain
First-aid effect Repairs sunburned skin in 72 hours May worsen sensitivity

Senior beauty mentor Linda revealed: “Three tests must be done before applying it to the face – test for heavy metal residues, allergens, and skin barrier values. In my handled cases, 23% of people crashed due to self-mixing with acidic products.”

In such situations, immediately:

  1. Rinse with saline solution for 10 minutes
  2. Apply refrigerated collagen mask
  3. Stop using all active ingredients within 48 hours

This year’s viral “Tokyo High Society Therapy” requires strict pairing:
STEP1 Ultrasonic cleaning →
STEP2 Ion introduction →
STEP3 Low-temperature calming. The entire process is harder to book than buying Hermès.

A recent viral case is quite interesting: A Dubai princess received treatment on a yacht, but the beautician used the wrong concentration. Later, it was discovered that marine humidity caused changes in the product’s properties, leading to this being written into the 2024 operation manual’s precautions.

Special reminder to check the product batch number: The 2024 new packaging has an anti-counterfeiting hologram at the corner label (see image). California client Y (file number CA-112) used old stock inventory and developed white spots after combining it with phototherapy. She is still in litigation over the issue.