How to Make Sure Your Products Pass FDA‘s Label Exam!
It is critical that you make sure your products comply with FDA’s labeling regulations because the labels are usually the first things that an FDA inspector sees when they examine your products! At a quick glance, your labels may appear to be just fine because they...
Cosmetics – Who Must Register and List?
If you market cosmetic products, you probably have heard that with the passage of the Modernization of Cosmetics Regulation Act, or “MoCRA”, the FDA is now enforcing mandatory registration and listing requirements for the cosmetics industry. So who exactly must...
What Happens if You Fail an FSVP Inspection: FDA 483s, Warning Letters, and Import Alert
What Happens if You Fail an FSVP Inspection: FDA 483s, Warning Letters, and Import Alert The FEI is a unique identifier that FDA uses to identify firms associated with FDA regulated products. FDA is now placing importers on the Red List of Import Alert 99-41...
Understanding FDA Recommendations for Plant-Based Milk Alternatives
The popularity of dairy-free, plant-based milk alternatives is rising. These dairy-free options, such as almond milk, soy milk, and oat milk, offer a vegan-friendly and lactose-free alternative to traditional cow's milk. Recognizing the need for clear and informative...
Get Ready to Register: The Importance of Obtaining an FDA Establishment Identifier (FEI) for the Cosmetic Industry
On December 29, 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law. Under the MoCRA, registration of cosmetic manufacturers and processors and listing of cosmetics is now mandatory. Click here for a list of FDA’s deadlines for...
Know about the Global Presence of FDA
Does The FDA Operate Internationally? Did you know that approximately 10 to 15 percent of the U.S. food supply comes to this country internationally? That includes 53 percent of fresh fruit and 29 percent of vegetables. In addition, about 35 percent of medical devices...
History Of FDA
The History of the FDA and Why It Was Created The Food and Drug Administration (FDA) can be traced back to the Pure Food and Drug Act of 1906. It was during this time that the government aimed to prevent the sale of adulterated and misbranded food and drugs as...
New FDA Cosmetic Requirements!
In December of 2022, the Modernization of Cosmetics Regulation Act (MCRA) was passed. The MCRA amends the Federal Food Drug and Cosmetic Act, creating several new requirements for manufacturers, processors, and importers of cosmetics. Below are some of the new...
Sesame
As of January 1, 2023, FDA began requiring that labels of foods containing sesame to declare sesame as an allergen. That means that there are now 9 major allergens that must be declared on food labels. These allergens are: Milk Eggs Fish Crustacean shellfish Tree nuts...
How FDA Regulates Protective Face Masks Such as N95 Masks and Surgical Masks
UPDATE 05.05.20 Emergency Use Authorization for Respirators FDA granted Emergency Use Authorization (EUA) for certain filtering facepiece respirators (“respirators”) and other personal protective equipment during the COVID-19 public health emergency. Under an EUA, FDA...
How FDA Regulates Hand Sanitizers
FDA regulates hand sanitizers (antiseptic hand wash products) as over the counter (OTC) drug products. They are drug products because they are used to prevent disease. Therefore, hand sanitizer products must comply with FDA’s drug regulations.To market hand sanitizers...
FDA Registration
What is FDA Registration? Establishments or facilities that manufacture, label, package, or perform certain other operations on foods, drugs, medical devices, tobacco, or biologics are required to register with FDA. A registered facility receives a unique registration...
FDA Import Requirements
What are FDA import requirements? All imported FDA-regulated products must: Be manufactured, processed, packed, and held under sanitary conditions. Not be forbidden or restricted for sale in the country the product is produced or exported from. Not be adulterated...
Basic Steps for Importing Products into the US
New importers often ask, “what exactly are the steps needed to start importing FDA-regulated products”? Of course, the “steps” vary depending on the types of products you are importing, the country of origin, how the products are intended to be used, and many other...
New FDA Import Alert to Enforce the Foreign Supplier Verification Program (FSVP) Rule
08/12/19: FDA has recently published Import Alert 99-41, “Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP)...
FDA Refusals –What You Should Do If You Receive an FDA Notice of Refusal
FDA may detain an imported shipment whenever it finds a violation of the Federal Food, Drug and Cosmetic Act (“FFDCA”) via an import exam. When FDA detains the shipment, the Agency will mail a Notice of Detention (“detention notice”) to the importer and importer’s...
How to Handle an FDA Import Detention
FDA may detain an imported product if, during an import exam, FDA finds that the product appears to violate the Federal Food, Drug and Cosmetic Act (“FFDCA”). When FDA detains the product, the Agency will mail a Notice of Detention and Hearing (“detention notice”) to...
FDA Import Alerts – What They Are and How to Get off Them
The Federal Food Drug and Cosmetic Act (“FFDCA”) provides FDA the authority to automatically detain imported products including foods, pharmaceutical drugs, medical devices, cosmetics, tobacco products, biologics, and radiation-emitting devices due to any previous...
FDA Now Accepting Applications for the Voluntary Qualified Importer Program (VQIP)
VQIP is a voluntary program in which food importers may participate to expedite release of their human or animal food shipments. FDA will not examine or sample shipments that are imported under VQIP unless warranted by public health reasons or for auditing purposes....
What Exactly is the Legal Status of CBD Oil?
Update 12/12/18! Congress has passed the 2019 Farm Bill which, if signed into law by the President, will lift federal restrictions on hemp production. As CBD is derived from hemp, this could lead to changes in the legal status of CBD oil products which, as noted in...
Foreign Supplier Verification Program (FSVP)
FDA has begun to enforce the FSVP rule which requires food importers to maintain documentation and records verifying that certain steps have been taken to ensure that the foods they import meet US food-safety standards. Most food importers have been required to comply...
FDA Announces Compliance Dates for New Nutrition Facts Labeling Requirements
In 2016, FDA published new requirements for food nutrition labeling that significantly change the appearance of the Nutrition Facts panels and the information required to be declared on the label. FDA provided time for companies to implement the changes and recently...