Registrations & Approvals: Cosmetics
FDA’s legal authority over cosmetics is unique,
as cosmetic products and ingredients are not subject to FDA premarket
approval, and cosmetic firms – not FDA – are responsible for substantiating
the safety of a cosmetic product and its ingredients. However, cosmetics
are
regulated by the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Fair
Packaging and Labeling Act (FPLA), which prohibit the marketing of
adulterated or misbranded cosmetics. If a cosmetic product is deemed
misbranded or adulterated, or if a cosmetic firm fails to comply with safety
regulations, then FDA may pursue enforcement action against products or
firms that violate the law.
TSG offers numerous consulting services to the cosmetic and personal care
products industry. Our consultants assist with a variety of product
stewardship issues that may be encountered, including:
▲Preparing safety assessments for
ingredients
▲Reporting adverse events
▲Providing
import/export advice
▲Responding to concerns regarding a
company’s product
▲Conducting audits of cosmetic manufacturers to assure compliance with
Good Manufacturing Practices (GMP) guidelines
▲Reviewing cosmetic labeling for compliance with FDA requirements
▲Evaluating the safety of cosmetic ingredients
▲Preparing color additive petitions for submission to FDA for approval
▲Advising on safety and environmental issues associated with the use of
nanotechnology
TSG and our European extension,
TSGE, have compiled all the information
required for EU cosmetic product dossiers. Together, we have devised and
commissioned safety and efficacy testing of cosmetics, toiletries, personal
care products and household products destined for marketing and sale in the
EU. Our cosmetics team is knowledgeable in all aspects of EU Directive
76/768/EEC, including:
▲Qualitative and quantitative composition of the product
▲The physico-chemical specifications of the raw materials and finished
product
▲Purity of the cosmetic product
▲Method of manufacture
▲Human health safety assessment of the finished product
▲Proof of effect claimed for the cosmetic product
Safety Evaluation without Animal Testing
TSG, in coordination with TSGE, provides general
advice on the obligations and impact that the EU animal testing ban imposes
on businesses. Our consultants determine how a company must proceed to
comply with the EU Directive in order to market and sell their product in
Europe. We also provide advice and strategies on how to address data
deficiencies using QSARs, read-across, waivers, public domain data, data
sharing and alternatives to animal tests.
 |
||||||||||
| Key Contacts | ||||||||||
| ||||||||||
