federal and state restrictions and regulations on industries that
produce, distribute, import or export dietary supplements, foods,
drugs, medical devices and cosmetics are a matter of concern to
everyone doing business within those industries. Future Food and
Drug Administration (FDA) and California Department of Health Services
(DHS) regulation and enforcement will only create more difficulty
for affected companies.
firm is dedicated to helping drug, supplement, food, cosmetic and
medical device companies navigate the complex regulatory landscape.
W. Patrick Noonan P.C. represents companies who need assistance
not only with the FDA and DHS, but also with the Drug Enforcement
Administration, Federal Trade Commission, and Consumer Products
Safety Commission. Visit our State Regulation section to learn more
about our expertise in interfacing with California administrative
and enforcement agencies. In addition, the firm is experienced in
assisting clients in civil litigation in federal and state courts.
on the Practice Area of your choice to learn more about our specific
Dietary Supplements & Foods
Patrick Noonan P.C. provides counsel and assistance to companies
and individuals involved in all areas of both the California Food
and Drug Branch and FDA regulation of prescription and over-the-counter
firm assists clients with NDA/ANDA product approvals and investigational
new drug ("IND") applications.
have broad experience in legal issues concerning FDA and state regulation
of manufactured drug products including: inspections, adverse drug
reports, recalls, warning letters, labeling requirements, compliance
with drug good manufacturing, Prescription Drug Marketing Act, drug
master files, import and export issues including import detentions
and submission of FDA 766 relabeling applications, OTC monograph
requirements and prescription and OTC drug listing requirements.
We can further assist clients with the promotion and marketing of
Patrick Noonan P.C. has also assisted companies in complying with
the requirements of the Drug Enforcement Administration (DEA) concerning
the manufacturing, distribution, importing and exporting of controlled
substances and listed chemicals and certain machines subject to
the Chemical Diversion and Trafficking Act of 1988.
W. Patrick Noonan P.C. practice includes advising and assisting
individuals and companies manufacturing and marketing conventional
foods and beverages, medical foods, dietary supplements, functional
foods, food and color additives, new dietary ingredients in meeting
both FDA and state regulatory requirements for these products and
INGREDIENTS AND ENFORCEMENT
Patrick Noonan P.C. provides assistance and counsel to clients in
meeting the legal requirements for:
claims for foods and dietary supplements
labeling requirements for foods and dietary supplements
Content claims for foods and dietary supplements
Party Literature provisions for dietary supplements
content and claims review
of nutritional support and other label and labeling requirements
for dietary supplements
and export requirements for foods and dietary supplements
day Notification for new dietary ingredients used for dietary
Affirmation of GRAS status for ingredients and GRAS notifications
Acid Can Food regulatory filings
firm can assist clients in preparing for food good manufacturing
practice ("GMP") inspections, responding to warning letters, dietary
supplement courtesy letters and assisting in the defense of FDA
assist clients in meeting the advertising substantiation requirements
of the Federal Trade Commission for foods and dietary supplements,
and we also represent companies in proceeding before the National
Advertising Division of the Better Business Bureau.
firm provides counsel to medical device companies in understanding
the obtaining compliance with FDA's regulation of medical device
product approval, manufacturing and marketing.
Patrick Noonan P.C. assists clients in product approval issues including
investigational device exemption (IDE) requirements, clinical studies
and Section 510K premarket notification.
also provide counsel on FDA regulation of marketed products including:
inspections, FDA 483's, warning letters, recalls, quality system
regulations (QSR) medical device reporting (MDR's) and other FDA
the area of cosmetics, our firm provides counsel and advice to many
companies involved in the importing, manufacturing, distribution
and sale of cosmetic products. This counsel includes advice on the
colors and ingredients in product formulations, labeling claims,
advertising and marketing programs.
firm also provides assistance to California companies requiring
export certificates for sale of product in the international market.
Patrick Noonan P.C. has been extensively involved in the formation
and continued success of the Beauty Industry West organization.