The FDA guidelines often read with such gray area that I myself find it confusing and often frustrating to read through even after almost 15 years experience in the business!. With the busy holiday season just around the corner, this seemed like a super time to go back over the FDA website to help our customers understand what is needed in body care labeling.
Good manufacturing practices are essential when creating and packaging Cosmetics & Soaps. Often times the gray area I talked about above comes from knowing the difference. Is it soap? Is it a cosmetic? Is it a drug or maybe it's a combination hybrid?! This has been very confusing over the years and this should help clarify this, or that is my hope at least.
True soap is NOT included in regulations by the FDA but rather the Consumer Product Safety Commission: http://www.cpsc.gov/ Over the years this has been a STRONG debate in the world of hand crafted soaps and cosmetics. I actually recently got confirmation on what IS needed on a soap label and what truly defines it as soap directly from the CPSC. This is copied and pasted from a response they emailed to me:
The Consumer Product Safety Commission (CPSC) regulates true
soaps that are made primarily of fats and alkalis and that are manufactured for
consumer use. The CPSC has no specific labeling requirements for such soaps.
However, if the product meets the definition of a hazardous substance, under the
Federal Hazardous Substances Act (FHSA) it may require cautionary labeling as
specified under the statute.
Section 2(p)(1) of the FHSA, 15 U.S.C. § 1261(p)(1), requires
that hazardous substances bear certain cautionary statements on their labels.
These statements include: signal words; affirmative statements of the principal
hazard(s) associated with a hazardous substance: the common or usual name, or
chemical name of the hazardous substance; the name and place of business of the
manufacturer, packer, distributor, or seller; statements of precautionary
measure to follow; instructions when appropriate, for special handling and
storage; the statement “Keep out of the reach of children” or its practical
equivalent; and, when appropriate, first aid instructions.
A product is determined to be a hazardous
substance if the substance or a mixture of substances is toxic, corrosive, an
irritant, a strong sensitizer, is flammable or combustible, or generates
pressure through decomposition, heat or other means, and if the substance or
mixture of substances may cause substantial personal injury or substantial
illness during customary or reasonably foreseeable handling or use, including
reasonably foreseeable ingestion by children. A determination that a product is
toxic may be based on the results of animal tests or on human experience.
It is the responsibility of a manufacturer or
importer of a product to determine whether its product meets the definition of a
hazardous substance and, if so, to fulfill its obligations under the FHSA for
appropriate precautionary labeling. The U.S. Consumer Product Safety
Commission does not perform pre-market clearance for household products
containing hazardous substances nor does it certify those products.
The Food, Drug and Cosmetic Act specifically
excludes soap because soap is not defined in the act. In administering the act,
the Food & Drug Administration interprets the term “soap” to apply only to
articles that meet the following conditions:
1)
The bulk of the nonvolatile matter in the product consists
of an alkali salt of fatty acids and the detergent properties of the article are
due to the alkali-fatty acid compounds; and
2)
The product is labeled, sold and represented only as
soap.
The interpretation goes on to state that products intended to
cleanse the body and which are not “soap” as defined above are considered
“cosmetics” regulated by FDA.
If your product meets the definition above (1 & 2) then
it would be subject to the Federal Hazardous Substances Act. If the product
meets the definition of a hazardous substance it is required to be labeled for
the hazards it presents to the consumer during reasonable and foreseeable
use.
I stand by my long time belief that "MOST" melt and pour soap is still considered a cosmetic and thus requires labeling per the FDA guidelines. If you look at a list of standard ingredients for melt and pour soap, you find that they are primarily comprised of detergents and other chemical ingredients and not fats (vegetable oils, animal fats like lard etc.) and alkalis (potassium or sodium hydroxide) or the product of mixing a fat and an alkali like sodium cocoate = soap created by the combination of sodium hydroxide and coconut oil. This is a list of a pretty basic melt and pour soap:
Glycerin, Propylene Glycol, Sodium Stearate, Sodium Laureth Sulfate, Sorbitol, Cocos Nucifera (Coconut) Oil, Sodium Myristate, Triethanolamine, Sodium Laurate, Sodium Cocoate, Water.
To me that isn't true soap and thus should be labeled as a cosmetic as it is not primarily a fat and alkali base. In this particular melt and pour, the top ingredients, Glycerin and Propylene Glycol are neither a fat OR an alkali.
Although true soap does not require by law ingredients declaration, I personally find it a good practice to always label what is in your product. People often have allergies or are sensitive to a certain ingredient and this way, you are protecting them and yourself by letting them know in advance what is in your product.
Most
cosmetics out there ARE NOT correctly labeled. This includes the big
guys. I find this page really defines it but it is imperative that as a
cosmetics manufacturer you read the entire section on the FDA website.
They will gladly answer questions if you should have them. They get many
questions so please be patient waiting for a response. Bottom line, be careful & use
good manufacturing practices and above all READ the Cosmetics section
on the FDA website before you label or sell your products. This is the
link to the entire Cosmetics section of their site.
http://www.fda.gov/Cosmetics/default.htm
Here are some basics with regards to labeling cosmetics in the United States.
Summary of Regulatory Requirements for Labeling of Cosmetics Marketed in the United States
From the Cosmetic Labeling Manual
October 1991; updated June 18, 2009
Cosmetics
marketed in the United States, whether manufactured here or imported
from abroad, must be in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act (FP&L Act), and the regulations published under the authority of these laws.
The
regulations published by the Food and Drug Administration (FDA) are all
codified in Title 21, Code of Federal Regulations (21 CFR). The regulations applicable to cosmetics are stated at 21 CFR, parts 700 to 740 (21 CFR 700 to 740). The color additive regulations applicable to cosmetics are found at 21 CFR 73, 74, 81 and 82.
The
FD&C Act defines cosmetics as articles intended to be applied to
the human body for cleansing, beautifying, promoting attractiveness, or
altering the appearance without affecting the body's structure or
functions. Included in this definition are products such as skin creams,
lotions, perfumes, lipsticks, fingernail polishes, eye and facial
make-up preparations, shampoos, permanent waves, hair colors,
toothpastes, deodorants, and any material intended for use as a
component of a cosmetic product. Soap products consisting primarily of
an alkali salt of fatty acid and making no label claim other than
cleansing of the human body are not considered cosmetics under the law.
Cosmetics That Are Also Drugs
Products
that are cosmetics but are also intended to treat or prevent disease,
or affect the structure or functions of the human body, are considered
also drugs and must comply with both the drug and cosmetic provisions of
the law. Examples of products which are drugs as well as cosmetics are
anticaries toothpastes (e.g., "fluoride" toothpastes), suntanning
preparations intended to protect against sunburn, antiperspirants that
are also deodorants, and antidandruff shampoos.
Most currently
marketed cosmetics which are also drugs are over-the-counter drugs.
Several are new drugs for which safety and effectiveness had to be
proved to the agency before they could be marketed. A new drug is a drug
which is not generally recognized by experts as safe and effective
under the conditions of intended use or which has become so recognized
but has not been used to a material extent or for a material time under
such conditions.
The regulatory requirements for drugs are more
extensive than the requirements applicable to cosmetics. For example,
the FD&C Act requires that drug manufacturers register every year
with the FDA and update their lists of all manufactured drugs twice
annually. Additionally, drugs must be manufactured in accordance with
current good manufacturing practice regulations as codified at 21 CFR
210 and 211.
For additional information, refer to Is It a Cosmetic, a Drug, or Both? (Or Is It Soap)?
Adulterated or Misbranded Cosmetics
The
FD&C Act prohibits the distribution of cosmetics which are
adulterated or misbranded. A cosmetic is considered adulterated if it
contains a substance which may make the product harmful to consumers
under customary conditions of use; if it contains a filthy, putrid, or
decomposed substance; if it is manufactured or held under insanitary
conditions whereby it may have become contaminated with filth, or may
have become harmful to consumers; or if it is not a hair dye and it
contains a non-permitted color additive. Coal-tar hair dyes bearing on
the label the caution statement prescribed by law and that give
"patch-test" instructions are exempted from the adulteration provision
even if they are irritating to the skin or are otherwise harmful to the
human body. Eyelash and eyebrow dyes are not included in this exemption.
All dyes used in eyelash and eyebrow dye products must be approved by
the FDA for such use.
A cosmetic is misbranded if its labeling is
false or misleading, if it does not bear the required labeling
information, or if the container is made or filled in a deceptive
manner. For additional information, see Key Legal Concepts: "Interstate Commerce," "Adulterated," and "Misbranded."
Cosmetic Labeling
The
cosmetics distributed in the United States must comply with the
labeling regulations published by the FDA under the authority of the
FD&C Act and the FP&L Act. Labeling means all labels and other
written, printed or graphic matter on or accompanying a product. The
label statements required under the authority of the FD&C Act must
appear on the inside as well as any outside container or wrapper.
FP&L Act requirements, e.g., ingredient labeling and statement of
the net quantity of contents on the principal display panel, only apply
to the label of the outer container. The labeling requirements are
codified at 21 CFR 701 and 740. Cosmetics bearing false or misleading
label statements or otherwise not labeled in accordance with these
requirements may be considered misbranded and may be subject to
regulatory action.
The principal display panel, i.e., the part of
the label most likely displayed or examined under customary conditions
of display for sale (21 CFR 701.10), must state the name of the product,
identify by descriptive name or illustration the nature or use of the
product, and bear an accurate statement of the net quantity of contents
of the cosmetic in the package in terms of weight, measure, numerical
count, or a combination of numerical count and weight or measure. The
declaration must be distinct, placed in the bottom area of the panel in
line generally parallel to the base on which the package rests, and in a
type size commensurate with the size of the container as prescribed by
regulation. The net quantity of contents statement of a solid, semisolid
or viscous cosmetic must be in terms of the avoirdupois pound and
ounce, and a statement of liquid measure must be in terms of the U.S.
gallon of 231 cubic inches and the quart, pint, and fluid ounce
subdivisions thereof. If the net quantity of contents is one pound or
one pint or more, it must be expressed in ounces, followed in
parenthesis () by a declaration of the largest whole units (i.e., pounds
and ounces or quarts and pints and ounces). The net quantity of
contents may additionally be stated in terms of the metric system of
weights or measures.
The name and place of business of the firm
marketing the product must be stated on an information panel of the
label (21 CFR 701.12). The address must state the street address, city,
state, and zip code. If a firm is listed in a current city or telephone
directory, the street address may be omitted. If the distributor is not
the manufacturer or packer, this fact must be stated on the label by the
qualifying phrase "Manufactured for ......" or "Distributed by ......"
or similar, appropriate wording.
The Tariff Act of 1930 requires that all imported articles state on the label the English name of the country of origin.
Declaration of Ingredients
Cosmetics
produced or distributed for retail sale to consumers for their personal
care are required to bear an ingredient declaration (21 CFR 701.3).
Cosmetics not customarily distributed for retail sale, e.g., hair
preparations or make-up products used by professionals on customers at
their establishments and skin cleansing or emollient creams used by
persons at their places of work, are exempt from this requirement
provided these products are not also sold to consumers at professional
establishments or workplaces for their consumption at home.
The
ingredient declaration must be conspicuous so that it is likely to be
read at the time of purchase. It may appear on any information panel of
the package, i.e., the folding carton, box wrapping if the immediate
container is so packaged, and may also appear on a firmly affixed tag,
tape or card. The letters must not be less than 1/16 of an inch in
height (21 CFR 701.3 (b)). If the total package surface available to
bear labeling is less than 12 square inches, the letters must not be
less than 1/32 of an inch in height (21 CFR 701.3(p)). Off-package
ingredient labeling is permitted if the cosmetic is held in tightly
compartmented trays or racks, it is not enclosed in a folding carton,
and the package surface area is less than 12 square inches (21 CFR
701.3(i)).
The ingredients must be declared in descending order of
predominance. Color additives (21 CFR 701.3(f)(3)) and ingredients
present at one percent or less (21 CFR 701.3(f)(2)) may be declared
without regard for predominance. The ingredients must be identified by
the names established or adopted by regulation (21 CFR 701.3(c)); those
accepted by the FDA as exempt from public disclosure may be stated as
"and other ingredients" (21 CFR 701.3(a)).
Cosmetics which are
also drugs must first identify the drug ingredient(s) as "active
ingredient(s)" before listing the cosmetic ingredients (21 CFR
701.3(d)).
All label statements required by regulation must be in
the English language and must be placed on the label or labeling with
such prominence and conspicuousness that they are readily noticed and
understood by consumers under customary conditions of purchase (21 CFR
701.2).
Label Warnings
Cosmetics which may be hazardous to
consumers when misused must bear appropriate label warnings and
adequate directions for safe use. The statements must be prominent and
conspicuous. Some cosmetics must bear label warnings or cautions
prescribed by regulation (21 CFR 740). Cosmetics in self-pressurized
containers (aerosol products), feminine deodorant sprays, and children's
bubble bath products are examples of products requiring such
statements.
Although the FD&C Act does not require that
cosmetic manufacturers or marketers test their products for safety, the
FDA strongly urges cosmetic manufacturers to conduct whatever
toxicological or other tests are appropriate to substantiate the safety
of their cosmetics. If the safety of a cosmetic is not adequately
substantiated, the product may be considered misbranded and may be
subject to regulatory action unless the label bears the following
statement: Warning--The safety of this product has not been determined.
Sec. 21 CFR 740.10.
Tamper-Resistant Packaging
Liquid oral
hygiene products (e.g., mouthwashes, fresheners) and all cosmetic
vaginal products (e.g., douches, tablets) must be packaged in
tamper-resistant packages when sold at retail. A package is considered
tamper resistant if it has an indicator or barrier to entry (e.g.,
shrink or tape seal, sealed carton, tube or pouch, aerosol container)
which, if breached or missing, alerts a consumer that tampering has
occurred. The indicator must be distinctive by design (breakable cap,
blister) or appearance (logo, vignette, other illustration) to preclude
substitution. The tamper-resistant feature may involve the immediate or
outer container or both. The package must also bear a prominently placed
statement alerting the consumer to the tamper-resistant feature. This
statement must remain unaffected if the tamper-resistant feature is
breached or missing. Sec. 21 CFR 700.25.
Law Enforcement Authority
For
enforcement of the law, the FDA may conduct examinations and
investigations of products, inspect establishments in which products are
manufactured or held, and seize adulterated (harmful) or misbranded
(incorrectly or deceptively labeled or filled) cosmetics. Adulterated or
misbranded foreign products may be refused entry into the United
States. To prevent further shipment of an adulterated or misbranded
product, the agency may request a federal district court to issue a
restraining order against the manufacturer or distributor of the
violative cosmetic. The FDA may also initiate criminal action against a
person violating the law. Examples of products seized in recent years
are nail preparations containing methyl methacrylate or formaldehyde,
various eyebrow and eyelash dye products containing prohibited coal-tar
dyes, and products contaminated with harmful microorganisms. For further
information, see FDA Authority Over Cosmetics.
Further
questions regarding regulatory requirements for marketing cosmetics
should be directed to the Food and Drug Administration, Center for Food
Safety and Applied Nutrition, Office of Cosmetics and Colors (HFS-100),
5100 Paint Branch Parkway, College Park, MD 20740, (240) 402-1130.
Questions regarding requirements for marketing products which are also
drugs should also be addressed to FDA's Center for Drug Evaluation and Research.
Cosmetic claims are a big thing as well. This outlines more what you can and can not say about your product. THIS IS VERY IMPORTANT! This is copied and pasted directly from the FDA website page:
http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/default.htm
Cosmetic Labeling & Label Claims
Overview
April 25, 2006; updated January 23, 2012
Overview
April 25, 2006; updated January 23, 2012
The
following information is a brief introduction to cosmetic labeling
requirements. For a more thorough explanation of cosmetic labeling
regulations, see FDA's Cosmetic Labeling Manual and the cosmetic labeling regulations themselves (21 CFR parts 701 and 740). Firms also may wish to discuss their labeling needs with a consultant.
Proper
labeling is an important aspect of putting a cosmetic product on the
market. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act
(FPLA). These laws and their related regulations are intended to
protect consumers from health hazards and deceptive practices, and to
help consumers make informed decisions regarding product purchase.
It
is illegal to introduce a misbranded cosmetic into interstate commerce,
and such products are subject to regulatory action. Some of the ways a
cosmetic can become misbranded are
- its labeling is false or misleading
- its label fails to provide required information
- its required label information is not properly displayed
- its labeling violates requirements of the Poison Prevention Packaging Act of 1970 [FD&C Act, sec. 602; 21 U.S.C. 362]
Does FDA pre-approve cosmetic product labeling?
No.
Neither the FD&C Act nor the FPLA requires cosmetic labeling to
undergo pre-market approval by FDA. It is the manufacturer's and/or
distributor's responsibility to ensure that products are labeled
properly. Failure to comply with labeling requirements results in a
misbranded product.
Some labeling terms you should know
Before proceeding with a discussion of labeling requirements, it is helpful to know what some labeling terms mean:
- Labeling. This term refers to all labels and other written, printed, or graphic matter on or accompanying a product [FD&C Act, sec. 201(m); 21 U.S.C. 321(m)].
- Principal Display Panel (PDP). This is the part of the label most likely displayed or examined under customary conditions of display for sale [21 CFR 701.10].
- Information Panel.
Generally, this term refers to a panel other than the PDP that can
accommodate label information where the consumer is likely to see it.
Since the information must be prominent and conspicuous [21 CFR
701.2(a)(2)], the bottom of the package is generally not acceptable for
placement of required information, such as the cosmetic ingredient
declaration.
Is it permitted to label cosmetics "FDA Approved"?
No.
As part of the prohibition against false or misleading information, no
cosmetic may be labeled or advertised with statements suggesting that
FDA has approved the product. This applies even if the establishment is
registered or the product is on file with FDA's Voluntary Cosmetic Registration Program
(VCRP) (see 21 CFR 710.8 and 720.9, which prohibit the use of
participation in the VCRP to suggest official approval). False or
misleading statements on labeling make a cosmetic misbranded [FD&C
Act, sec. 602; 21 U.S.C. 362].
What about therapeutic claims?
Promoting
a product with claims that it treats or prevents disease or otherwise
affects the structure or any function of the body will cause the product
to be considered a drug under the FD&C Act, section 201(g). FDA has
an Import Alert in effect for cosmetics labeled with drug claims. For more information on drug claims, see Is It a Drug, a Cosmetic, or Both? (Or Is It Soap?).
How should products be labeled if they are both drugs and cosmetics?
If a product is an over-the-counter (OTC) drug
as well as a cosmetic, its labeling must comply with the regulations
for both OTC drug and cosmetic ingredient labeling [21 CFR 701.3(d)].
The drug ingredients must appear according to the OTC drug labeling
requirements [21 CFR 201.66(c)(2) and (d)] and the cosmetic ingredients
must appear separately, in order of decreasing predominance [21 CFR
201.66(c)(8) and (d)]. Contact FDA's Center for Drug Evaluation and Research (CDER) for further information on drug labeling.
What languages are acceptable?
All
required labeling information must be in English. The only exception to
this rule is for products distributed solely in a U.S. territory where a
different language is predominant, such as Puerto Rico. If the label or
labeling contains any representation in a foreign language, all label
information required under the FD&C Act must also appear in that
language [21 CFR 701.2(b)].
What labeling information is required?
The following information must appear on the principal display panel:
- An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].
- An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].
The following information must appear on an information panel:
- Name and place of business. This may be the manufacturer, packer, or distributor. [21 CFR 701.12].
- Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..." [21 CFR 701.12].
- Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.
- Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 740]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. Flammable cosmetics are an example.
- Ingredients. If the product is marketed on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. As an alternative, when cosmetics are distributed on a mail-order basis, the package mailed to the consumer may contain readily visible instructions for locating the ingredient declaration, such as in a product catalog (currently interpreted as including a website), or instructions for requesting a copy of the ingredient declaration. Mail-order distributors must respond promptly to such requests [21 CFR 701.3(r)]. Remember, if the product is also an OTC drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above.
Happy Cosmetics, Soap and Candle Making!
Flicker
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