3. How are the laws and regulations
different for cosmetics and drugs?
Regulatory requirements for cosmetics in U.S.
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulati
ons/ucm074201.htm
5. I- Approval
Drugs are subject to FDA approval process
No cosmetic products are approved by FDA before they are sold
to the public
FDA is only able to regulate cosmetics after products are
released to the marketplace
FDA does not have a premarket approval system for cosmetic
products or ingredients, with the important exception of color
additives.
6. Approval
• approved by FDA
• specifications, and restrictions
Certification
• a number of color additives
must be batch certified by FDA
Identity and specifications
• identity and specifications
stated in the Code of Federal
Regulations (CFR).
Use and restrictions
8. • A cosmetic that contains a color additive that
does not comply with the applicable FDA
regulation will cause the cosmetic product to
be considered to be adulterated
9. II-Good Manufacturing Practice
GMP is an important factor in assuring that your cosmetic
products are neither “adulterated “nor “misbranded”.
No regulations set specific GMP requirements for cosmetics
In contrast, the law requires strict adherence to GMP
requirements for drugs,
Regulations specifying minimum current GMP requirements
for drugs.
10. III- Registration
• FDA does not have the authority to require manufacturers to
register their cosmetic establishments, file data on ingredients,
• FDA maintains a “voluntary data collection program”.
Companies that wish to participate in the program forward data
to FDA.
11. FDA Voluntary Cosmetic Registration Program
(VCRP)
• VCRP is not a cosmetic approval program
• An FDA post-market reporting system for use by manufacturers,
packers, and distributors of cosmetic products that are in
commercial distribution in the United States.
• Its mission to protect consumers, gives cosmetic manufacturers
and distributors access to valuable information and supports the
safety evaluation of cosmetic ingredients.
• https://www.fda.gov/cosmetics/registrationprogram/default.htm
12. • Under FDA's Voluntary Cosmetic Reporting Program
(VCRP), manufacturers are encouraged to:
• Register their manufacturing sites;
• Register their products and ingredients; and
• Report any health-related consumer comments (e.g.,
allergy reactions).
13. IV-Labeling
A cosmetic product must be labeled according to cosmetic
labeling regulations.
OTC drugs must be labeled according to OTC drug regulations,
including the "Drug Facts" labeling,
Drug/cosmetic products must have combination OTC
drug/cosmetic labeling.
E.g. drug ingredients must be listed alphabetically as "Active
Ingredients," followed by cosmetic ingredients, listed in order of
predominance.
14. V- Safety & Efficacy
For drugs, it is required that safety and efficacy be established
before sales and marketing
FDA cannot require companies to do safety testing of their
cosmetic products before marketing
FDA has consistently advised manufacturers to use whatever
testing is necessary to ensure the safety of their products and
ingredients.
15. Safety & Efficacy
FDA has stated that "the safety of a product can be adequately
substantiated through reliance on already available toxicological
test data on individual ingredients and on product formulations
that are similar in composition to the particular cosmetic.
If the safety of a cosmetic product has not been substantiated,
the product's label must read:
WARNING: The safety of this product has not been determined
16. Cosmetic Ingredient Review
(CIR)
An independent, non-profit scientific body established in 1976
Personal Care Products Council and Food and Drug Administration
(FDA) and the Consumer Federation of America (CFA)
Review and assess the safety of ingredients used in cosmetics in the
U.S.
CIR’s safety opinions are published in peer-reviewed scientific literature
(International Journal of Toxicology) and are publically available on its
website, www.cir-safety.org
17. 1
• Ingredient(s) are safe as used
2
• Ingredient(s) are safe with qualifications
3
• Ingredient(s) are unsafe
4
• Insufficient data or information to make a
safety determination
Cosmetic Ingredient Review
(CIR)
18. Cosmetic manufacturers are responsible for using only safe and
suitable ingredients in their products
Safety considerations need to carefully evaluated, recognizing
that, in the past, systemic toxicity has resulted from cosmetic
use.
An example is hexachlorophene-containing cosmetic products,
which were responsible for the death of 36 babies in France in
1972.
19. Can FDA order the recall of a hazardous cosmetic from
the market?
FDA is not authorized to order recalls of cosmetics, it monitors
companies that conduct a product recall and may request a product
recall if the firm is not willing to remove dangerous products from
the market without FDA's written request.
20. Does FDA test cosmetics or recommend testing labs?
Although FD&C Act does not subject cosmetics to premarket
approval by FDA, it collects samples for examination and analysis
as part of cosmetic facility inspections, import inspections, and
follow-up to complaints of adverse events associated with their
use.
21. What actions can FDA take against companies or
individuals who market adulterated or misbranded
cosmetics??
FDA may take regulatory action if we have reliable information
indicating that a cosmetic is adulterated or misbranded.
FDA has restricted the use of certain ingredients in cosmetics
FDA issued a rule banning the use of methylene chloride in
cosmetics
Methylene chloride is a poisonous or deleterious substance that
may render cosmetic products injurious to users,” due to the
potential cancer risks of exposure to the substance.
22. What actions can FDA take against companies or
individuals who market adulterated or misbranded
cosmetics??
If a cosmetic was to contain methylene chloride, it would be
considered adulterated, and FDA could take an enforcement
action such as: “Seizure”
24. What are the Regulatory requirements for
cosmetics in Egypt?
• Cosmetic registration is a two-step process involving
registration of products with Egyptian ministry of health
(MOH) and trademark registration.
• Only the companies local to Egypt with trade licenses can
register the cosmetic products in Egypt.
• http://www.eda.mohp.gov.eg/Articles.aspx?id=49
29. 1
•Low inventory of ingredients
2 •Low chemical exposure
3 •Low production of environmental waste
4 •Low cost of final formula
5 •Low complication during scale-up
32. Development process
1 2 3 4 5 6
Learn about the
existing products
The Idea’s phase Get a formula equipment
Select
benchmarking
rationale behind
the formula
