The Sunscreen Filter
& Development Ltd
Dr. Nadim Shaath is the President of Alpha Research
& Development, Ltd. in White Plains, NY. He has over
30 years of experience as Chairman of the Chemistry
Department at SUNY-Purchase and the CEO of Kato
Worldwide and Nickstadt-Moeller. He has just published his new manuscript entitled: “Healing Civilizations: The Search for Therapeutic Essential Oils and
Nutrients” Cameron Books, Petaluma, CA.
CONGRESS is currently debating how to amend the Federal Food, Drug and Cosmetic Act to clarify the regulatory framework with respect to certain
non-prescription drugs that are marketed
without an approved new drug application. The proposed bill will be known as:
“Over-the-Counter Monograph Safety,
Innovation and Reform Act of 2017.” As
you know, sunscreens in the US are regulated as OTC drugs, and all the ultraviolet
filters allowed for use have been approved
through the so-called “monograph ingredients process.” The only exceptions are
avobenzone and ecamsule.
The FDA, the PASS Coalition (Public
Access to Sunscreens) and others in the
cosmetics industry have been actively
engaging in meetings with members
of Congress and other legislators while
pleading their case for more suitable final
sunscreen regulations in the US.
The PASS Coalition met with the FDA
earlier this summer to review new and
previously submitted pending sunscreen
ingredients applications (the so-called
TEA ingredients). This was followed up
by a letter from the PASS Coalition in July.
Among the points of agreement that were
reached with the FDA, the following items
• Regulatory pathways must be flex-
ible enough to accommodate sunscreen
• Pending sunscreen ingredients
should be considered under the Sunscreen
Innovation Act (SIA) and any new products will be considered under the newly
reformed OTC pathway.
• The specific testing and absorption requirements described in the FDA’s
November, 2016 guidance document entitled “Nonprescription Sunscreen Drug
Products—Safety and Effectiveness Data”
remain a recommendation, and the agency will be flexible in considering alternative testing regimes for sponsors in order
to meet the agency’s standard for products
generally recognized as safe and effective.
FDA’s testing standards should be periodically reviewed and assessed.
• It has been recognized that the New
Drug Application (NDA) is difficult for
sunscreen ingredients and that sponsors of
sunscreen ingredients should have alternate
pathways to establish safety and efficacy.
The director of the Center for Drug
Evaluation and Research (CDER), Dr.
Janet Woodcock, responded promptly and
stated that the FDA concurs, in principle,
to our summary but added that it was im-
portant to add context to some of the ma-
• As to specific testing and absorption
requirements, the FDA remains flexible in
considering validated alternative testing
procedures in support of a determina-
tion of general recognition of safety and
• Although the New Drug Application
(NDA) process may be viewed as difficult, there have been sunscreen products
approved under NDAs. This includes
products containing ecamsule, one of
the proposed sunscreen ingredients addressed by the Sunscreen Innovation
Act; thus, some sunscreen products with
ecamsule can currently be marketed in
this country. The monograph process does
not lessen data standards to establish the
safety and efficacy of any sunscreen ingredient and the FDA has used flexibility
in reviewing ingredients. The monograph
process, however, clearly will allow more
flexibility in formulating individual sunscreen products.
The FDA held three meetings in
Congress the first week of August and
followed it up with an Aug. 23 webinar
that focused mainly on“user-fees”but had
some important information as well. The
Some Californians didn’t have the brightest ideas to protect themselves during the recent solar eclipse.