75
using validated test methods are required. Plant raw material controls include genus/spe-
cies identification, growing location, harvesting time, processing of plant parts, storage and
shipping conditions and qualification of new suppliers. Quality control tests for the drug
substance consist of identification, strength, weight, assay (biological activity) and testing
to preclude impurities and contaminants for pesticides, endogenous toxins, exogenous tox-
ins, radioactive materials, heavy metals and microbials. The dosage form should be tested
for identification, assay, content uniformity, dissolution and degradation products. Lot-to-
lot consistency must be confirmed, including equivalence before and after manufacturing
changes and between the clinical material and the to-be-marketed product.6
A botanical drug is uniquely defined by the plant raw material, the manufacturing
process used in preparation and the chemical characteristics of the drug substance and final
product. Overall, botanical drug manufacturers have little to cheer about in terms of the con-
ditions for approval. There is, however, a special office at the agency (the Botanical Review
Team) staffed with experts in herbal medical products to assist potential manufacturers.
IND Submissions and Approval
The process of approving a botanical drug begins with the manufacturer submitting an
Investigational New Drug (IND) application. The initial trial is the opportunity to observe
Figure 1.
The Big Picture for Botanicals
Development Paths for Botanical Products
Botanical
Product
OR
No
No
Yes
Yes
Is it intended for use as
drug 21 U.S.C. 321 (g)?
Is it intended for use as dietary
supplement 21 U.S.C. 321 (ff)?
Used to diagnose,
cure, mitigate, treat
or prevent disease
Ingested to affect
structure or function
of the body
Consumed for nutritive
value to reduce the risk of a
disease or a health-related
condition to promote health
Cosmetic
Drug
Conventional Food or Dietary
Supplement with Unqualified
or Qualified Health Claim
Dietary Supplement
structure/function
claims comply with
all requirements of
21 U.S.C. 343 (r)(6)
Food
What is
intended
use?
Applied to body for
cleansing, beautifying,
or altering appearance
Consumed for its
taste, aroma or
nutitive value
FDA Approval of Botanical Drugs
using validated test methods are required. Plant raw material controls include genus/spe-
cies identification, growing location, harvesting time, processing of plant parts, storage and
shipping conditions and qualification of new suppliers. Quality control tests for the drug
substance consist of identification, strength, weight, assay (biological activity) and testing
to preclude impurities and contaminants for pesticides, endogenous toxins, exogenous tox-
ins, radioactive materials, heavy metals and microbials. The dosage form should be tested
for identification, assay, content uniformity, dissolution and degradation products. Lot-to-
lot consistency must be confirmed, including equivalence before and after manufacturing
changes and between the clinical material and the to-be-marketed product.6
A botanical drug is uniquely defined by the plant raw material, the manufacturing
process used in preparation and the chemical characteristics of the drug substance and final
product. Overall, botanical drug manufacturers have little to cheer about in terms of the con-
ditions for approval. There is, however, a special office at the agency (the Botanical Review
Team) staffed with experts in herbal medical products to assist potential manufacturers.
IND Submissions and Approval
The process of approving a botanical drug begins with the manufacturer submitting an
Investigational New Drug (IND) application. The initial trial is the opportunity to observe
Figure 1.
The Big Picture for Botanicals
Development Paths for Botanical Products
Botanical
Product
OR
No
No
Yes
Yes
Is it intended for use as
drug 21 U.S.C. 321 (g)?
Is it intended for use as dietary
supplement 21 U.S.C. 321 (ff)?
Used to diagnose,
cure, mitigate, treat
or prevent disease
Ingested to affect
structure or function
of the body
Consumed for nutritive
value to reduce the risk of a
disease or a health-related
condition to promote health
Cosmetic
Drug
Conventional Food or Dietary
Supplement with Unqualified
or Qualified Health Claim
Dietary Supplement
structure/function
claims comply with
all requirements of
21 U.S.C. 343 (r)(6)
Food
What is
intended
use?
Applied to body for
cleansing, beautifying,
or altering appearance
Consumed for its
taste, aroma or
nutitive value
FDA Approval of Botanical Drugs