Why do I need an FDA compliance attorney?


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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