regulatory approval process of drug, cosmetic and neutraceutical in usa.

1. NAME: RICHA PATEL
MPHARM SEM: I
ROLL NO: 27
REGULATORYAFFAIRS
KBIPER
REGULATORY APPROVAL PROCESS FOR DRUG,
NEUTRACEUTICALS, HERBALS & COSMETICS IN USA

2. PHARMACEUTICAL MARKET
• Regulated: USA, EU, JAPAN (follow ICH pattern)
• Semi-regulated: India, ASEAN countries, Russia, China, Brazil (country
specific product registration guideline are followed)
• Non-regulated: African countries ( minimum documentation is required
for drug approval process)

3. An overview of the drug approval process
• Developing a new drug requires great amount of research work in drug
chemistry, manufacturing, controls, pre-clinical science and clinical
trials.
• Drug development can generally be divided into phases.
 The preclinical phase
 Clinical phases

5. DRUG APPROVAL IN US
• The united states has perhaps the world’s most stringent standards for
approving new drug.
• Drug approval standards in the united states are considered by many to
be the most demanding in the world.

6. Different type f applications that can be
submitted to FDA
Name of the application For what
IND (investigational new drug) It is an application filled to the FDA in order
to start clinical trials in humans on the basis
of the data obtained from the preclinical
trials.
NDA (new drug application) If clinical studies confirm that a new drug is
relatively safe and effective and will not
pose unreasonable risks to patients.
ANDA (abbreviated new drug application) It is made for approval of generic drugs.
BLA (biologic license application) Biologic products are approved for
marketing under the provisions of the
public health service act.

7. INVESTIGATIONAL NEW DRUG

8. NEW DRUG APPLICATION

9. ANDA

10. COSMETIC APPROVAL IN USA
• FDA does no approved cosmetics, although we do approve color
additives used in cosmetics.
• It is the responsibility of cosmetic manufacturer to ensure, before
marketing their products, that the products are safe when used as
directed in their label or under customary condition of use.

11. CONTINUE
• The two most important laws pertaining to cosmetics marketed in the
united states are the federal food, drug and cosmetic act and the fair
packaging and labeling act.
• FDA regulates cosmetics under the authority of these laws.
• The law does not require cosmetic products and ingredients, other than
color additives to have FDA approval before they go on the market.

12. Voluntary cosmetic registration program
• FDA’s voluntary cosmetic registration program is a
reporting system for use by manufacturers, packers, and
distributors of cosmetic products that are in commercial
distribution in the united states.

13. What kind of products are cosmetics under the
law?
• The FD&C act defines cosmetics by their intended use, as “articles 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”.
• Among the products included in this definition are skin moisturizers, perfumes,
lipstick, fingernail polishes, eye and facial makeup, cleansing shampoo, hair
colors and deodorants etc.
• It does not include soap.
• If your product meets the regulatory definition of SOAP it is regulated by the
consumer product safety commission (CPSC) not by FDA.

14. • The FD&C act prohibited the marketing of adulterated or misbranded
cosmetic.
• If the product is intended for a therapeutic use such as treating or
preventing disease or to affect the structure or function of the body, it’s
drug or medical device even if it affects the appearance.

15. Does FDA approve cosmetics before they go
on the market?
• FDA’S legal authority over cosmetics is different from over other
products they regulated such as drug, biologics, and medical devices.
• Under the law, cosmetic products and ingredients do not need FDA
premarket approval with the exception of color additives.

16. Who is responsible for substantiating the safety of
cosmetics?
• Companies and individuals who manufacture or market cosmetics have
a legal responsibility to ensure the safety of their products.
• Neither the law nor FDA regulations require specific tests to
demonstrate the safety of individual products or ingredients.

17. Can FDA inspect cosmetics manufacturers?
• FDA can and does inspect cosmetic manufacturing facilities
to assure cosmetic product safety and determine whether
cosmetics are adulterated or misbranded under the FD&C
act o FPLA.

18. Do cosmetics firms need to register with FDA
or get an FDA license to operate?
• Under the law, manufacturers are not required to register
their cosmetic establishments or file their product
formulations with FDA, and no registration number is
required to import cosmetic into the US.

19. Labeling requirement of cosmetic
• The cosmetics marketed in the United States, whether they
are manufactured here or are imported from abroad, must
comply with the labelling requirements of the Federal Food,
Drug, and Cosmetic (FD&C) Act, the Fair Packaging and
Labelling (FP&L) Act, and the regulations published by the
Food and Drug Administration under the Authority of these
two laws.
Fair Packaging and Labelling Act
• To ensure that packages and their labels provide consumers
with accurate information about the quantity of contents and
facilitate value comparisons.

20. What is cosmetic?
• A cosmetic is a product, except soap, intended to be
applied to the human body for cleansing,
beautifying, promoting attractiveness, or altering
the appearance.
When is a cosmetic also a drug?
• A cosmetic is also a drug when it is intended to
cleanse, beautify or promote attractiveness as well
as treat or prevent disease or otherwise affect the
structure or any function of the human body.

23. Prominence and conspicuousness
• Panel display at purchase
• Panel size
• Style and size of letters
• Background contrast
• Obscuring designs, vignettes
• Panel display: The required information must be on a panel which is presented or
displayed under customary conditions of purchase. This eliminates placement of required
information on a bottom panel of a cosmetic unless it is very small and customarily
picked up by hand where inspected for possible purchase.
• Panel Size: The label must be large enough to provide sufficient space for prominent
display of the required information.
• Style and Size of Letters: The type must be of such size, and at least of the required
minimum size, and of such style that the required label statements are easily readable.
• Background Contrast: The contrast must be sufficient to make the required label
statements conspicuous and easily readable.
• Obscuring Designs, Vignettes: The required statements must not be obscured by
vignettes or other designs or by crowding with other printed or graphic matter.

24. Order of prominence

25. Example of label

26. List of banned ingredient in cosmetic
• Although it’s against the law to use any ingredient that makes a cosmetic harmful when used as
intended, FDA has regulations that specifically prohibit or restrict the use of the following
ingredients in cosmetics:
• Bithionol. The use of bithionol is prohibited because it may cause photocontact sensitization (21
CFR 700.11).
• Chlorofluorocarbon propellants. The use of chlorofluorocarbon propellants in cosmetic
aerosol products intended for domestic consumption is prohibited (21 CFR 700.23).
• Chloroform. The use of chloroform in cosmetic products is prohibited because it causes cancer
in animals and is likely to be harmful to human health, too. The regulation makes an exception
for residual amounts from its use as a processing solvent during manufacture, or as a by product
from the synthesis of an ingredient (21 CFR 700.18).
• Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide). These
are prohibited in cosmetic products because they may cause serious skin disorders (21 CFR
700.15).

27. • Hexachlorophene. Because of its toxic effect and ability to penetrate human skin,
hexachlorophene (HCP) may be used only when no other preservative has been shown to be as
effective. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be
used in cosmetics that are applied to mucous membranes, such as the lips (21 CFR 250.250).
• Mercury compounds. Mercury compounds are readily absorbed through the skin on topical
application and tend to accumulate in the body. They may cause allergic reactions, skin irritation,
or neurotoxic problems. The use of mercury compounds in cosmetics is limited to eye area
products at no more than 65 parts per million (0.0065 percent) of mercury calculated as the metal
and is permitted only if no other effective and safe preservative is available. All other cosmetics
containing mercury are adulterated and subject to regulatory action unless it occurs in a trace
amount of less than 1 part per million (0.0001 percent) calculated as the metal and its presence is
unavoidable under conditions of good manufacturing practice (21 CFR 700.13).
• Methylene chloride. It causes cancer in animals and is likely to be harmful to human health, too
(21 CFR 700.19).

28. • Prohibited cattle materials. To protect against bovine spongiform
encephalopathy (BSE), also known as "mad cow disease," cosmetics may
not be manufactured from, processed with, or otherwise contain, prohibited
cattle materials. These materials include specified risk materials*, material
from no ambulatory cattle, material from cattle not inspected and passed, or
mechanically separated beef. Prohibited cattle materials do not include
tallow that contains no more than 0.15 percent insoluble impurities, tallow
derivatives, and hides and hide-derived products, and milk and milk
products** (21 CFR 700.27).
• Sunscreens in cosmetics. Use of the term "sunscreen" or similar sun
protection wording in a product's labelling generally causes the product to
be subject to regulation as a drug or a drug/cosmetic, depending on the
claims. However, sunscreen ingredients may also be used in some cosmetic
products to protect the products’ colour. The labelling must also state why
the sunscreen ingredient is used, for example, "Contains a sunscreen to
protect product colour." If this explanation isn’t present, the product may be
subject to regulation as a drug (21 CFR 700.35). For more information on
sunscreens, refer to Tanning Products.

29. • Vinyl chloride. The use of vinyl chloride is prohibited
as an ingredient of aerosol products, because it causes
cancer and other health problems (21 CFR 700.14).
• Zirconium-containing complexes. The use of
zirconium-containing complexes in aerosol cosmetic
products is prohibited because of their toxic effect on
lungs of animals, as well as the formation of
granulomas in human skin (21 CFR 700.16).

30. Color additives: some basic requirement
• Approval. All color additives used in cosmetics (or any other FDA-regulated
product) must be approved by FDA. There must be a regulation specifically
addressing a substance's use as a color additive, specifications, and restrictions.
• Certification. In addition to approval, a number of color additives must be batch
certified by FDA if they are to be used in cosmetics (or any other FDA-regulated
product) marketed in the U.S.
• Identity and specifications. All color additives must meet the requirements for
identity and specifications stated in the Code of Federal Regulations (CFR).
• Use and restrictions. Color additives may be used only for the intended uses
stated in the regulations that pertain to them. The regulations also specify other
restrictions for certain colors, such as the maximum permissible concentration in
the finished product.

31. Color additive category
• Colors subject to certification: These color additives are derived
primarily from petroleum and are sometimes known as "coal-tar dyes" or
"synthetic-organic" colors. Except in the case of coal-tar hair dyes, these
colors must not be used unless FDA has certified that the batch in
question has passed analysis of its composition and purity in FDA's own
labs. If the batch is not FDA-certified, don't use it.
• These certified colors generally have three-part names. The names
include a prefix FD&C, D&C, or External D&C; a color; and a number.
An example is "FD&C Yellow No. 5." Certified colors also may be
identified in cosmetic ingredient declarations by color and number
alone, without a prefix (such as "Yellow 5").

32. Continue..
• Color exempt from certification: These color additives are obtained
primarily from mineral, plant, or animal sources. They are not subject to
batch certification requirements. However, they still are considered
artificial colors, and when used in cosmetics or other FDA-regulated
products, they must comply with the identity, specifications, uses,
restrictions, and labeling requirements stated in the regulations [21 CFR
73].
• Straight color: "Straight color" refers to any color additive listed in 21
CFR 73, 74, and 81 [21 CFR 70.3(j)].

33. Continue…
• Lake: A lake is a straight color extended on a substratum by
adsorption, coprecipitation, or chemical combination that
does not include any combination of ingredients made by a
simple mixing process [21 CFR 70.3(l)]. Because lakes are
not soluble in water, they often are used when it is important
to keep a color from "bleeding," as in lipstick.

34. Color additive list
• Color additive that are exempt from certification and
permitted for use in cosmetics are given under 21 CFR part
73
• Color additive that are subjects to certification and permitted
for use in cosmetics include straight and lake color given
under 21 CFR part 74 and 21 CFR part 82

35. Dietary supplements
• Dietary supplements include such ingredients as vitamins, minerals,
herbs, amino acids, and enzymes.
• Dietary supplements are marketed in forms such as tablets, capsules,
softgels, gelcaps, powders, and liquids.
• No premarket approval needed.

36. Dietary supplements
• FDA regulates both finished dietary supplement products and dietary
ingredients. FDA regulates dietary supplements under a different set of
regulations than those covering "conventional" foods and drug products.
Under the Dietary Supplement Health and Education Act of 1994
(DSHEA):
• Manufacturers and distributors of dietary supplements and dietary
ingredients are prohibited from marketing products that are adulterated
or misbranded. That means that these firms are responsible for
evaluating the safety and labelling of their products before marketing to
ensure that they meet all the requirements of DSHEA and FDA
regulations.
• FDA is responsible for taking action against any adulterated or
misbranded dietary supplement product after it reaches the market.

37. Do dietary supplements need to be approved
by the FDA?
• FDA is not authorized to review dietary supplement
products for safety and effectiveness before they
are marketed. The manufacturer and distributors of
dietary supplements are responsible for making
sure their products are safe BEFORE they go to
market.
• No premarket approval needed.

38. New dietary ingredient (NDI) notification
When Must You Submit a New Dietary Ingredient
Notification?
• If you plan to market a dietary supplement that contains
a new dietary ingredient, you must submit to FDA, at
least 75 days before the dietary ingredient is introduced
or delivered for introduction into interstate commerce,
information that is the basis on which you have
concluded that a dietary supplement containing the new
dietary ingredient will reasonably be expected to be
safe.

39. What Must You Submit
• FDA regulations require that you submit an original and two (2) copies of the notification
and all of its attachments. You must also provide in the notification:
• Your name and complete address.
• The name of the new dietary ingredient. If the new dietary ingredient is an herb or other
botanical, you must include the Latin binomial name (including the author).
• A description of the dietary supplement or dietary supplements that contain the new
dietary ingredient, including the:
– level of the new dietary ingredient in the product;
– conditions of use of the product stated in the labelling or if no conditions of use are
stated, the ordinary conditions of use; and
– history of use or other evidence of safety establishing that the dietary ingredient,
when used under the conditions recommended or suggested in the labelling of the
dietary supplement, will be reasonably be expected to be safe.
• Any reference to published materials must be accompanied by reprints or photo
static copies.
• Any material in a foreign language must be accompanied by a translation.
• A signature by a person designated by you who can be contacted if we have questions.

40. LABEL OF DIETARY SUPPLEMENT