Drugs & Cosmetics

 

DRUGS

The Federal Food Drug and Cosmetic Act (FDCA) and FDA regulations define the term drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and as “articles (not food) intended to affect the structure or any function of the body of man or other animals.”


Moreover, almost any ingested or injectable product that, through its label or labeling (including internet websites, promotional sheets, and other marketing material), is claimed to be beneficial for such uses will be regulated by FDA as a drug.


All drugs are regulated by FDA and all drugs must be safe and effective for their intended uses. Most drugs are new drugs requiring compliance with an OTC monograph or being subject to a new drug application (NDA) or an abbreviated new drug application (ANDA – used for generic drugs) and FDA approved for their labeled uses. Drugs must also be properly formulated, not adulterated, properly labeled and marketed.


All drugs must be manufactured, processed, packed, and labeled in facilities that are registered under FDA drug establishment registration regulations. Facilities that manufacture, process, pack, and label drugs must also submit drug listings to FDA for every drug they distribute in or introduce into the United States. This applies to domestic as well as foreign drug manufacturers, processors, packers, labelers. Foreign drug manufacturers must also appoint a U.S. Agent for FDA purposes when they register their facilities.


Imported drugs that are not in compliance with all FDA regulations or are from unregistered drug facilities will be subject to FDA import detention, FDA Import Alerts, and FDA import refusal of admission.


But of course, importing drugs into the United States brings unique challenges and BYM! is able to help doing this step in a very competitive way.


We can significantly reduce the risks associated with drug importation and drug distribution.

 

COSMETICS

Importing cosmetics into the United States can be very profitable. However, it is critical that the cosmetic manufacturer or cosmetic importer understand and apply the FDA cosmetic regulations properly to all cosmetic labels, cosmetic ingredients, and cosmetic marketing and advertising.


Like all FDA-regulated products, cosmetics are defined as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleaning, beautifying, promoting attractiveness, or altering the appearance.” Cosmetics distributed in the USA must have correct cosmetic labeling, contain safe cosmetic ingredients, and be pure and of high quality.


FDA regulates some products as drugs even though the product manufacturers or importers initially thought the products could be marketed as cosmetics.


The cosmetic label, cosmetic advertising and cosmetic ingredients dictate how FDA will regulate the product. Any claims that a product can prevent disease (for instance, as a sun protection cosmetic) or that it will affect the structure or function of the human body (for instance, as an anti-wrinkle cosmetic cream) are drug claims. Such claims are not permitted on cosmetic labels, cosmetic advertising, cosmetic Internet sites or other cosmetic promotional materials. Other examples of impermissible drug claims include cosmetic hair restoration claims, cosmetic cellulite reduction claims, cosmetic varicose vein treatments, cosmetic skin whiteners.


Correct cosmetic labels and cosmetic marketing claims are critical to successfully importing cosmetics into the United States.

 

COLOR ADDITIVES

Color additives are subject to a strict system of approval under Federal Food, Drug, and Cosmetic Act (FD&C Act). Color additive violations are a common reason for detaining imported cosmetic products offered for entry into U.S.

 

If your product (except coal-tar hair dyes) contains a color additive, by the law FD&C Act you must adhere to requirements for:

 

  • Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance's use as a color additive, specifications, and restrictions.

  • Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.

  • Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).

  • Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

 

The regulation separates approved color additives into two main categories: those subject to certification and those exempt from certification.

 

  • Colors subject to certification. These color additives are derived primarily from petroleum and are sometimes known as "coal-tar dyes" or "synthetic-organic" colors.

    • Except in the case of coal-tar hair dyes, these colors must not be used unless FDA has certified that the batch in question has passed analysis of its composition and purity in FDA's own labs. If the batch is not FDA-certified, don't use it.

    • These certified colors generally have three-part names. The names include a prefix FD&C, D&C, or External D&C; a color; and a number. An example is "FD&C Yellow No. 5."

  • Colors exempt from certification. These color additives are obtained primarily from mineral, plant, or animal sources. They are not subject to batch certification requirements. However, they still are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations.

In addition, the regulations refer to other classifications, such as straight colors and lakes.

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