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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
FDA NEWS

FDA Compliance News: science-based health and safety information you can trust

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FDA Compliance News: science-based health and safety information you can trust.


Food technology company Eat Just Inc has received a “no questions” letter from the U.S. Food and Drug Administration as part of one of the agency’s first pre-market consultations for a new kind of meat, poultry and seafood made from cells instead of raised and slaughtered animals. The company is now working with the U.S. Department of Agriculture on necessary approvals before this cultivated chicken is served at a restaurant near you.

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OTC COSMETICS

Sunscreens, Fluoride Toothpaste, Antiperspirants, Dandruff Shampoos, Skin Protectants, Topical Analgesics are OTC cosmetics, and therefore both cosmetics and drug products in the United States.

DIETARY SUPPLEMENTS

The Dietary Supplements Market size is projected to reach $220.8 billion by 2027, and more than one-third of Americans take dietary supplements in form of tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids.

FDA CONSULTANTS

We do understand that running a business can be stressful. So, pass on some of that.

Have someone else, like our FDA Consultants, handle all the FDA Compliance paperwork, while you concentrate on advertising and selling your products our services. Deal?

SUNSCREEN & SUN PROTECTION

Myths vs. Facts: sunscreen and sun protection for some only?

In fact, just 1-2% of all skin cancers occur in Blacks, 2-4% occur in Asians, and 4-5% in Hispanics.

INSOMNIA

Nearly 70 million Americans have a sleep disorder. Combined direct and indirect costs for insomnia in the United States exceed $100 billion annually.

FULFILLMENT BY AMAZON (FBA)

How to ship your products to Amazon U.S. warehouses, and avoid FDA detention of your cargo.

FDA REGISTRATION NUMBER

Failure to register your domestic or foreign facility or establishment with the United States Food and Drug Administration before introducing regulated products into interstate commerce, is a prohibited act.

FSVP

Foreign Supplier Verification Program (FSVP) and Food Safety Systems Recognition Arrangements (SRA): Currently, Canada, Australia and New Zealand, are the only countries that have signed SRA with the FDA, for the purpose of Foreign Supplier Verification Program (FSVP).

FDA DETENTION

If you are unable to overcome the appearance of a violation, your product will be refused admission and you can work with U.S. Customs and Border Protection (CBP) and FDA to destroy the product or export it from the U.S within 90 days of the refusal.

OMUFA FDA USER FEES

FDA recognizes that the FY 2022 facility fee rates were an increase of 19 percent in comparison to the FY 2021 facility fee rates, and that increase was largely attributed to the decrease in the number of fee-liable facilities. Any lessons learned for the upcoming FY 2023 facilities rates?

NIOSH CERTIFICATION

In an average year, the National Institute of Occupational Safety and Health (NIOSH) receives approximately 400 requests and grants 250 new approvals.

HUMAN FOOD & ANIMAL CELLS

Before human food made from cultured animal cells can enter the market, the facility in which it is made needs to meet applicable U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) requirements.

FDA NEWS IN FOREIGN LANGUAGES
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ENREGISTREMENT FDA

Les entreprises étrangères exportant vers les États-Unis doivent identifier un agent de la FDA des États-Unis tel que ITB HOLDINGS LLC au cours du processus d’enregistrement. Puisque la nomination d’un Agent Américain est obligatoire, autant en avoir un qui parle français et enregistre aussi votre entreprise auprès de la FDA.

REGISTRAZIONE FDA

La registrazione FDA è un prerequisito per esportare cibo negli Stati Uniti. Più di 10.026 aziende alimentari italiane sono registrate presso la FDA degli Stati Uniti. Se la tua azienda non rinnova la registrazione tra il 1° ottobre e il 31 dicembre 2022, devi ottenere un nuovo numero di registrazione FDA.

REGISTRO FDA

Más de 7.552 empresas alimentarias mexicanas y 4.611 españolas están registradas ante la FDA de Estados Unidos. Amplíe el mercado para sus productos, hoy. Se requiere que fabricantes y exportadores se registren ante la FDA y realicen una notificación previa a los envío de alimentos a EE.UU.

美国FDA注册

最低的美国 FDA 注册服务费用:

▪ 无隐藏费用
▪ 没有强制选项
▪ 只做你需要或想做的事
▪ 各种服务费减免
▪ 减少多家公司的开支
▪ 包括美国代理服务
▪ 额外收费的当天服务

यूएस एफडीए पंजीकरण

4217 से अधिक भारतीय खाद्य कंपनियां युनाइटेड स्टेट्स एफडीए के साथ पंजीकृत हैं, जिसकी आवश्यकता तब होती है जब आप अपने उत्पादों का निर्यात करते हैं। अमेरिकी सीमा शुल्क द्वारा अपने शिपमेंट को रोके जाने से बचें। समय और पैसा बचाएं।

미국 FDA 등록

3939개 이상의 한국 식품 회사가 제품을 수출할 때 요구되는 미국 FDA에 등록되어 있습니다. 미국 관세청에서 발송물을 억류하지 않도록 하십시오.

시간과 비용을 절약하십시오.