Industries
At FDAimports.com, LLC you will have access to consultants and lawyers with extensive experience in all industries regulated by the FDA and U.S. Department of Agriculture (“USDA”). Producing, marketing and distributing FDA and USDA regulated products require you to comply with an array of pre-shipment compliance requirements. Non-compliant foods, cosmetics, drugs or medical devices will ordinarily be treated as "misbranded" or "adulterated", and, therefore illegal. For long term success, your business must meet a myriad of regulatory requirements applicable to the following industries: food & beverages, cosmetics, dietary supplements, drugs, medical devices, electronic & radiological devices, alcohol, and tobacco.
At FDAImports.com, LLC we find The Way Through the regulatory maze for FDA, USDA, TTB, Customs, FTC, and EPA matters.
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FDA and Department of Agriculture (“USDA”) share regulatory authority over food. USDA regulates meat, poultry, eggs, and products made from meat, poultry, and eggs, while FDA regulates all other foods.
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FDA regulates the cosmetic industry. Frequently cosmetic companies run afoul of FDA regulations by making impermissible claims about their products or by including illegal ingredients, particularly colorants, in their products.
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FDA strictly monitors the dietary supplement industry. The supplements must comply with the food regulations, but also a unique set of regulations for ingredients, labeling, and product/ingredient claims.
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FDA possesses the greatest authority over drugs. Essentially, every drug must either comply with an FDA monograph for an over-the-counter (OTC) drug or obtain FDA premarket approval for its intended use.
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FDA regulates medical devices according to their classification. Some devices only require registering with FDA, while others must obtain FDA pre-market approval. Also, some must comply with additional requirements established by FDA.
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FDA regulates radiation emitting electronics products. This includes medical devices such as X-ray machines, but also common household devices such as television receivers and microwave ovens.
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Alcohol is regulated by numerous federal, state, and local government agencies. While the Alcohol and Tobacco Tax and Trade Bureau (TTB) has primary jurisdiction over the taxing and labeling of alcohol on the federal level, FDA and Customs also play a role.
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FDA only recently gained regulatory authority over tobacco products. Currently, this industry’s regulation remains in constant flux as FDA begins to implement the Family Smoking Prevention and Tobacco Control Act and issue regulations.
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