Determining whether your food or dietary supplement product is
compliant with FDA and FTC regulations, as well as determining the best
strategy from marketing can be a daunting task. At L. Capote, P.A. we
make the process easier by taking the guess work out of the process.
FDA REGISTRATION
FDA requires facilities that
manufacture, process, pack or store foods, drugs, and medical devices
marketed in the U.S. file registrations with FDA. In
addition, manufacturers of drugs and devices must list their products
with FDA. These registrations and listings must be completed annually
to stay in compliance with FDA regulations.
Under the Bioterrorism Act, foreign drug and device manufacturers
are required to provide to the
identity of known US importers. On importation
statement must be filed with FDA identifying the registration numbers
of various companies in the supply chain. We assist with filing Prior
Notices and will work closely with your Customs broker to ensure
compliance with Bioterrorism and Prior Notice. We will also act as U.S.
agent for foreign facilities.
FOODS & DIETARY SUPPLEMENTS
FDA regulates all
foods distributed in the U.S. FDA regulates foods for safety,
contamination, and proper labeling. L. Capote, P.A. conducts label and
ingredient reviews for all foods and dietary supplement in accordance
with FDA regulations. We help clients with obtaining FDA approval for
food additives. We also provide regulatory compliance with Nutrition
Labeling and Education Act including health claims, nutrient content
claims, formatting the labeling as well as advertising rules and
regulations under FTC. Our staff will also consult on the use of new
qualified health claims for conventional foods, ensuring compliance for
medical foods and formulas, as well as packaging materials.
Dietary supplements are allowed to have
structure/function claims, but not health claims. Can your company
tell the difference between the two? Let us educated you and help a
smooth transition for your dietary supplement from concept to market.
We will also provide advertising guidance for your dietary supplement
to ensure conformance with regards to testimonials, disclaimers, amount
of evidence to support certain claims and various other FTC
regulations. We will file your 30 Day Structure/Function Notification
with FDA.
Have you received an FDA Warning Letter? Have you been audited by
FDA? Let L. Capote, P.A. advise you on the best course of action with
each of these.
COSMETICS
Cosmetics marked in the US must comply with the
provisions of the Federal Food, Drug and Cosmetic Act, Fair Packaging
and Labeling Act and other federal regulations. Is your product
compliant? We can conduct ingredient and labeling review as well as an
analysis of any claims made on your website.
PHARMACEUTICALS & OTC DRUGS
One of the most highly regulated products on the market
are pharmaceuticals and OTC drugs. Are you complying with your OTC
monograph? Do you need to file an New Drug Application? L. Capote, P.A.
can prepare your orphan drug application, assist with implementing and
conducting necessary product recalls, educate and train your staff on
adverse event reporting compliance, prepare New Drug Applications and
Abbreviated New Drug Applications. We will conduct annual internal
audits of your facility so that if FDA comes knocking on your door you
can be assured that their inspection will run smoothly.
MEDICAL DEVICES
We can provide you with product development counseling,
including coordinating with investigators, third party reviews,
advertising requirements, and promotion of the device. We determine
whether a product requires a pre-market notification and what the
necessary registration and device listings may be. If a 510(k)
application needs to be filed we will put together the necessary
application material and file the application with FDA. Our staff
works with the FDA, to the extent possible, addressing any and all
concerns FDA may have with the device. We also work with scientists
and regulatory personnel in the pre-market process.
All medical device facilities, including distributors,
must have a quality system in place for tracing purposes as well as
ensuring the product is developed in accordance with FDA regulations.
Many facilities may be ISO certified, however FDA regulations require a
few more documents to be included in your manual. L. Capote, P.A. can
review, establish and find short comings with your quality system
program as well as provide training and consulting for Medical Device
Reporting. Our staff works efficiently to save you time and money.
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