Why do I need an FDA compliance attorney?
Reputable companies
that bring any technology or healthcare product to the market know the
importance of working with an experienced and credible FDA compliance
attorney. When you distribute and manufacture technological or healthcare
products, you come under the jurisdiction of various state and federal
agencies.
Food & Drug Administration (FDA)
and Federal Trade Commission (FTA)
These government
entities play the role of stopping bad healthcare and technological products in
the market.
Among these government
bodies, two of the important ones are Federal Trade Commission (FTA) and Food
& Drug Administration (FDA). Moreover, the district attorneys and state
attorney generals also enforce the state laws over various healthcare and
technological products.
Some of the categories of the products on
which the state and federal laws apply are:
·
Stem cell products
·
Homeopathic drugs
·
Biologics
·
Wellness software
·
Health or healthcare applications
·
OTC drugs
·
Food and drug additives
·
Medical devices
·
Medical applications
·
Cosmetics
·
Over-the-counter beauty products
·
Nutraceuticals and dietary supplements
·
Medical foods
Analysis of claims by FDA compliance
attorney
Whenever FDA and FTA
review healthcare, cosmetic or technological products, they regulate the
product in one of the classifications, such as cosmetics, dietary supplements,
nutraceuticals, etc. Sometimes, the FDA classifies the product as a combination
of two categories.
If you have the
ownership of a combination product, you must meet all the FDA’s legal
requirements for both categories. All the legal requirements by the government
entity must be challenging to understand. Therefore, you must seek legal advice
and assistance from an FDA compliance attorney.
The Food and Drug
Administration looks at the purpose and the use of medical, cosmetic, or
technological products. The investigation team uses all the labeling to
determine the purpose of your product in the market. It has broad yet strict
enforcement powers. Therefore, everything written on the label of your
product’s bottle or box will be investigated.
If you have a fear
that your product will come under any claims, get an FDA compliance lawyer
and make the process easy for yourself.
FDA compliance attorneys for dietary
supplements claims
Dietary supplements
are not defined by a single category laid out by the Food and Drug
Administration. They are a combination of a dietary substance, amino acid,
botanical substance, mineral, herb, and vitamin. They are used by people to
balance their unhealthy diets. The purpose of dietary supplements is to improve
health or to lose/gain weight.
However, you can only
sell dietary supplements with function or structure claims. If you put your
dietary supplements under disease or therapeutic claims, you would be
investigated by the Food and Drug Administration. An experienced FDA
compliance attorney will help you dodge these claims in court.
FDA compliance lawyers for cosmetics
Similarly, you can’t
make disease claims on cosmetic products as well. Common cosmetic products in
the market include lipsticks, deodorants, eye makeup, face makeup, hair colors,
and an extensive range of skin products.
Any product that is
used with the intention to pour or rub on the skin comes under this category.
If the FDA finds out that you have put a ‘disease’ claim on any cosmetic or
dietary product, your product will be considered misbranded. Therefore, you
would need a credible FDA compliance attorney to keep your head above
the waters.
The enforcement powers of the Food
and Drug Administration
The manufacturers and
distributors of dietary supplements, medical devices, cosmetic products, and
drugs make the biggest mistake of underestimating the enforcement powers of the
Food and Drug Administration and other federal and state agencies.
The serious actions
they can take against your company can be disastrous for your profit.
Therefore, you need the speed and zeal of a good FDA compliance lawyer
to establish a strong case.
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