Cosmetics vs. Drugs Classification Policy
Cosmetics vs. Drugs Classification Policy
A clear, product-by-product explanation of why every formula sold on shoplabache.com is legally and factually a cosmetic — never a drug, medicine, or medical device — under United States, Japanese, and European Union / UK law, and exactly which claims we do, and do not, make about what our products can do.
Why We Publish This Policy
This Cosmetics vs. Drugs Classification Policy explains, product by product and region by region, how La Bâché LC Bryant LLC ("La Bâché," "we," "us," or "our") determines and maintains the legal classification of every item we sell on shoplabache.com. We formulate small-batch skincare, hair care, and Homme grooming products in Philadelphia, Pennsylvania, and ship them to customers in the United States, Japan, and the European Union, EEA, and United Kingdom.
In every one of those markets, the law draws a firm line between a "cosmetic," a product intended to cleanse, beautify, promote attractiveness, or alter appearance, and a "drug," a product intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body in a therapeutic sense. That line determines which regulator has jurisdiction, which safety and clinical evidence standard applies, and which claims a brand is legally permitted to make. We take that line seriously, and this page sets out, in plain and specific language, exactly where every La Bâché product sits and why.
This policy should be read together with our Refund Policy, Terms of Service, Shipping Policy, Privacy Policy, and Legal Notice. It applies to every listing across our Skin, Hair, and Homme collections, and to all product descriptions, packaging, and advertising we publish, in the store or elsewhere.
Clear Classification Statement
We state this plainly, without qualification, so there is no ambiguity for customers, regulators, advertising platforms, or payment processors reviewing our store.
Every product sold by La Bâché is a cosmetic, not a drug. Our products do not cure, treat, mitigate, prevent, diagnose, or reverse any disease or medical condition, and no statement on our website, packaging, or advertising should be read as implying otherwise.
- Intended use. Every La Bâché formula is intended solely to cleanse, condition, moisturize, perfume, or improve the visible appearance of skin, hair, or beard — never to affect the structure or function of the body in a medical or therapeutic sense.
- No disease claims. We do not name, imply, or reference any disease, medical condition, or diagnosis, such as acne, eczema, psoriasis, dermatitis, rosacea, alopecia, or fungal or bacterial infection, anywhere in our marketing.
- No drug-only vocabulary. We avoid words that, under FDA, EU, and Japanese guidance, signal an intended drug use, including "treat," "cure," "heal," "prevent disease," "anti-inflammatory," "antibacterial," "clinically proven to treat," "reduces the symptoms of," and similar language, in any product title, description, or ad copy.
- Registered, not approved. Because our products are cosmetics, they are notified, listed, or registered with the relevant authority in each region, as explained in Section 4, rather than approved as drugs — a distinction we explain openly rather than blur.
How "Cosmetic" and "Drug" Are Defined
The cosmetic/drug distinction is not a marketing choice; it is written directly into statute in every market we serve. We rely on the following definitions to classify each product before it is ever listed for sale.
- United States. Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(i), a cosmetic is an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. A drug, under 21 U.S.C. § 321(g), is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body other than through appearance. A single product can legally be regulated as both if it makes both types of claims — which is precisely why we control our claims so carefully.
- European Union & United Kingdom. Regulation (EC) No 1223/2009 on cosmetic products, Article 2(1)(a), defines a cosmetic product as any substance or mixture intended to be placed in contact with external parts of the human body, or with teeth and mucous membranes, exclusively or mainly to clean, perfume, change appearance, protect, keep in good condition, or correct body odours. Products intended to restore, correct, or modify physiological functions by a pharmacological, immunological, or metabolic action fall instead under EU medicinal product law (Directive 2001/83/EC) and, in the UK, the Human Medicines Regulations 2012.
- Japan. The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律, the "PMD Act"), Article 2, defines a cosmetic (化粧品) as an item intended to be applied to the human body by rubbing, sprinkling, or similar methods, for cleansing, beautifying, enhancing attractiveness, altering appearance, or keeping skin or hair in good condition, whose action on the human body is mild. Products with a stronger, medically recognised effect are instead classified as quasi-drugs (医薬部外品) or pharmaceuticals (医薬品), which require separate approval we do not hold and do not claim to hold.
Regulatory Frameworks We Comply With
Select a region to see the specific regulatory framework that governs our cosmetic products there.
FDA Jurisdiction & the Modernization of Cosmetics Regulation Act (MoCRA)
Our U.S. cosmetics are regulated by the U.S. Food and Drug Administration under the FD&C Act and the Fair Packaging and Labeling Act, and, since December 2022, under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA does not require FDA "approval" of cosmetics before sale — cosmetics are not pre-approved the way drugs are — but it does impose direct compliance obligations that we meet.
Facility Registration
Our manufacturing facility is registered with the FDA as required by MoCRA, and that registration is renewed on the required biennial schedule.
Product Listing
Each La Bâché formula is listed with the FDA, including its ingredient composition, as required for every cosmetic product marketed in the United States.
Safety Substantiation
We maintain records substantiating the safety of every product for its intended use, as MoCRA requires, rather than relying on marketing claims alone.
Good Manufacturing Practice
Our small-batch production follows FDA cosmetic Good Manufacturing Practice guidance on hygiene, recordkeeping, and ingredient handling.
Regulation (EC) No 1223/2009 & the UK Cosmetic Products Framework
For orders shipped into the European Union and EEA, every product is notified through the Cosmetic Products Notification Portal (CPNP) before it is offered for sale, and a Responsible Person established within the EU is designated for our range, as Article 4 of Regulation (EC) No 1223/2009 requires for cosmetics placed on the EU market by a non-EU manufacturer such as La Bâché.
Cosmetic Product Safety Report
A Safety Report under Annex I of Regulation (EC) No 1223/2009, covering toxicological profile, stability, and microbiological quality, is prepared for each formula before EU sale.
Responsible Person
Our designated EU Responsible Person keeps the Product Information File available to member-state authorities and coordinates any required action.
UK Submit Cosmetic Product Notification (SCPN)
Products shipped to the United Kingdom are separately notified through the UK's SCPN system under the Cosmetic Products Enforcement Regulations 2013, post-Brexit.
INCI Labelling
Ingredient lists on every EU/UK-bound product follow International Nomenclature of Cosmetic Ingredients (INCI) naming, in descending order of concentration, per Annex VII.
The PMD Act & Japan's Cosmetic / Quasi-Drug Distinction
Cosmetics sold into Japan are governed by the PMD Act, administered by the Ministry of Health, Labour and Welfare (厚生労働省) and, for imported cosmetics, generally require a Marketing Authorization Holder or an appointed in-country partner to handle notification before distribution.
Cosmetic Notification
Standard cosmetics like ours are notified to the relevant prefectural governor before marketing, rather than pursuing the separate, more demanding quasi-drug (医薬部外品) approval pathway we do not use.
Negative & Positive Ingredient Lists
Every formula is checked against Japan's restricted, prohibited, and permitted-with-limits ingredient lists for cosmetics before it is offered to Japan-bound customers.
Japanese-Language Labelling
Full ingredient declarations and required safety information are made available in Japanese for Japan-bound orders, consistent with PMD Act labelling expectations.
No Quasi-Drug Claims
Because we hold cosmetic, not quasi-drug, status in Japan, we do not use quasi-drug-reserved terms such as 薬用 (medicated) on any Japan-bound listing.
State, National & Member-State Specific Rules
National frameworks are only the baseline. States and member states layer additional, cosmetic-specific rules on top, and we comply with the ones relevant to where a product is shipped.
Key U.S. State Cosmetic Laws
California — Prop 65
The Safe Drinking Water and Toxic Enforcement Act (Proposition 65) requires a warning if a product contains a listed substance above the applicable threshold. We review our formulas against the current Prop 65 list and label accordingly where required.
California — Cosmetic Fragrance and Flavor Ingredient Right to Know Act (SB 312)
This law requires disclosure of certain fragrance ingredients on a state-run ingredient database. Our scented formulas are reviewed against this requirement for California-bound sales.
California Cruelty-Free Cosmetics Act
We do not conduct or commission animal testing on our finished cosmetic products or ingredients, consistent with this Act's prohibition on the sale of newly animal-tested cosmetics in California.
Washington & Other State Ingredient Restrictions
Washington's Toxic-Free Cosmetics Act and similar state ingredient-restriction laws are reviewed against our formulas so that any restricted ingredient thresholds are respected for orders shipped to those states.
Notable EU Member-State & UK Requirements
France — ANSM Oversight
France's Agence nationale de sécurité du médicament et des produits de santé (ANSM) monitors cosmetic vigilance nationally; serious undesirable effects reported by French customers are escalated to ANSM through our Responsible Person, alongside the CPNP filing.
Germany — BfR Ingredient Guidance
We take account of opinions published by Germany's Bundesinstitut für Risikobewertung (BfR) on cosmetic ingredient safety when reviewing formulas intended for the German market.
United Kingdom — Post-Brexit Divergence
Where the UK's restricted-substance list has diverged from the EU's since Brexit, we apply the stricter of the two limits to any product sold into the UK.
Cross-EU — Allergen Labelling
The 26 (now expanded) fragrance allergens requiring on-pack disclosure under EU cosmetic law are identified and labelled on every scented product we ship into the EU and UK.
Japan-Specific Compliance Points
Act Against Unjustifiable Premiums and Misleading Representations
This consumer-protection law prohibits exaggerated or unsubstantiated effect claims in advertising; our Japan-bound marketing copy is reviewed against it before publication.
Act on Specified Commercial Transactions
Governs our disclosure obligations for mail-order sales into Japan, including return and cancellation terms, as detailed in our Refund Policy.
Import Notification (薬機法輸入届出)
Each shipment of cosmetics into Japan is accompanied by the required import notification confirming cosmetic, not pharmaceutical, classification.
Consumption Tax Handling
Japanese consumption tax is calculated and disclosed at checkout for Japan-bound orders, consistent with national tax rules for imported goods.
Our Product Classification Table
Every product currently sold on shoplabache.com is listed below with its classification, regulatory basis, and the intended use we state to regulators and customers alike.
| Product | Category | Classification | Intended Use (Stated Basis) | Regulatory Basis |
|---|---|---|---|---|
| Blueberry Luxé Élixir Facial Serum | Skin | Cosmetic | Visibly brightens and evens the appearance of skin tone; provides antioxidant, moisturizing, and conditioning benefits to the skin's surface. | 21 U.S.C. §321(i); Reg. (EC) 1223/2009 Art. 2; PMD Act Art. 2 |
| Élixir Romarin — Rosemary Mint Hair Oil | Hair | Cosmetic | Conditions hair and scalp, improves manageability and shine, and imparts fragrance; does not treat any scalp or hair-loss condition. | 21 U.S.C. §321(i); Reg. (EC) 1223/2009 Art. 2; PMD Act Art. 2 |
| Parfum D'Homme Balm — Brazilian Mandarin & Sandalwood | Homme | Cosmetic | Softens and conditions beard and skin, and perfumes; a grooming and fragrance balm, not a medicated or antiseptic product. | 21 U.S.C. §321(i); Reg. (EC) 1223/2009 Art. 2; PMD Act Art. 2 |
| Parfum D'Homme Serum — Brazilian Mandarin & Sandalwood | Homme | Cosmetic | Conditions facial skin and beard hair, improves appearance and softness, and perfumes; makes no disease-related or hair-growth claim. | 21 U.S.C. §321(i); Reg. (EC) 1223/2009 Art. 2; PMD Act Art. 2 |
| Complimentary Derm Roller (with Parfum D'Homme orders) | Homme accessory | Cosmetic Tool | A manual cosmetic-application accessory intended to aid product absorption during a grooming routine; not marketed or intended as a medical device for treating skin conditions. | Cosmetic accessory — not device-regulated in any of our shipping regions |
How this table is kept current. Whenever we introduce a new formula, reformulate an existing one, or expand into a new region, that product is classified using the definitions in Section 3 and added to this table before it is listed for sale, so this page always reflects our live catalog at shoplabache.com/collections/all.
Claims We Make & Claims We Will Never Make
Beautiful language is part of our brand; misleading language is not. Here is exactly how we express what our products do, and the specific claims we deliberately avoid.
Cosmetic Claims We Make
Truthful statements about appearance, sensation, and grooming — the legally appropriate scope for a cosmetic.
- "Visibly brightens and evens skin tone" (Blueberry Luxé Élixir)
- "Firms and plumps with antioxidant-rich extract"
- "Conditions, softens, and adds shine to hair and beard"
- "Lightweight, fast-absorbing, fragrant"
- "Fights the visible effects of environmental stressors"
- "Free of parabens, sulfates, and synthetic fragrance"
Claims We Will Never Make
Statements that would legally reclassify a product as a drug, or that Google Shopping and other advertising platforms treat as unsubstantiated health claims.
- "Cures acne" or "clears breakouts permanently"
- "Treats eczema, psoriasis, rosacea, or dermatitis"
- "Reduces inflammation" or "anti-inflammatory"
- "Regrows hair" or "stops hair loss / balding"
- "Kills bacteria / antibacterial / antifungal"
- "Clinically proven to treat" any named condition
- "Heals," "repairs damaged skin at the cellular level," or similar physiological-function claims
Comparative and superlative language. Where we use expressive, luxury-brand language such as "your skin deserves the extraordinary" or "a luminous, glass-skin glow," we treat it as subjective brand voice, not a measurable, verifiable efficacy claim, and we do not pair it with implied medical outcomes.
Labeling & Ingredient Transparency
Every product page on shoplabache.com carries a complete ingredient list, and we do not omit or obscure any ingredient to make a formula appear "cleaner" than it is.
- Full disclosure. Ingredients are listed in descending order of concentration, following International Nomenclature of Cosmetic Ingredients (INCI) naming, on every product description, matching the physical label shipped with the product.
- Function, not marketing name. Where we highlight a "hero" ingredient such as wild blueberry extract or rosemary, the surrounding claim describes a cosmetic function, appearance, conditioning, fragrance, never a therapeutic one.
- "Free of" claims are verified. When we state a product is free of parabens, sulfates, or synthetic fragrance, that statement is checked against the finished formula before publication, not assumed from the ingredient brief.
- Region-specific labelling. EU/UK-bound labels include the required allergen disclosures and Responsible Person details; Japan-bound labels include the required Japanese-language ingredient declaration; U.S. labels follow Fair Packaging and Labeling Act requirements for net quantity and ingredient declaration.
How Every Claim Is Reviewed
No product description, ad, or social post reaches the public without passing through this checklist first.
Draft Against This Policy
Copywriting is drafted using the "claims we make" vocabulary in Section 7 and checked against the "never make" list before it leaves the drafting stage.
Ingredient Cross-Check
Every claim is matched to the actual finished-formula ingredient list and function, so no claim outruns what the product genuinely contains or does.
Regional Compliance Pass
Region-bound copy (U.S., EU/UK, Japan) is checked against the specific frameworks in Sections 4–5 before it is enabled for that market's storefront.
Publish & Monitor
Once live, listings are periodically re-reviewed, and any customer or platform flag about a claim is investigated and corrected promptly.
Consumer Safety & Adverse Event Reporting
Being classified as a cosmetic does not lessen our responsibility for product safety. If you experience an unexpected reaction, we want to know immediately.
- How to report. Email bonjour@shoplabache.com or call +1 (215) 429-3436 with your order number, the product used, and a description of what happened, as soon as you notice a reaction.
- United States — MoCRA serious adverse event reporting. A serious adverse event, meaning an event resulting in death, a life-threatening experience, hospitalization, significant disfigurement, a birth defect, or an event requiring medical intervention to prevent such an outcome, is reported to the FDA within 15 business days of our becoming aware of it, with records maintained for the period MoCRA requires.
- EU / EEA / UK — cosmetovigilance. Serious undesirable effects reported by EU or UK customers are notified by our Responsible Person to the competent authority of the relevant member state or the UK, consistent with Article 23 of Regulation (EC) No 1223/2009 and UK cosmetic vigilance requirements.
- Japan — post-market reporting. Adverse reactions reported by Japan-based customers are logged and, where the reaction meets the relevant threshold, reported through our Japan compliance contact consistent with PMD Act post-market safety obligations.
- Recalls. If a formula is ever found not to meet the safety standard we hold it to, we will notify affected customers directly, remove the listing, and follow the recall procedures applicable in each affected region.
Changes to This Classification Policy
As we introduce new formulas, enter new shipping regions, or as cosmetic and drug regulation in the United States, Japan, or Europe evolves, we will update this page, including the product classification table in Section 6, to stay current. When we make a material change, we update the "Last Updated" date at the top of this page.
This policy does not retroactively change the classification basis under which a product already purchased was sold; it governs classification and claims going forward from the date shown above.
Questions About How We Classify a Product
If you would like more detail on how a specific product is classified, its regulatory notification status in your region, or its full ingredient list, our team replies personally — we aim to reply within one business day.
Reach us by phone, email, live chat on the site, or by writing to our Philadelphia office.
This Cosmetics vs. Drugs Classification Policy forms part of, and should be read alongside, our Refund Policy, Terms of Service, Shipping Policy, Privacy Policy, and Legal Notice. © 2026 La Bâché LC Bryant LLC. All rights reserved.