The US FDA releases Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products & API
On April 2023, the USFDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act” that helps to prevent and mitigate drug shortage.
FDA Adding Common Ingredient to the Major Food Allergen List Starting
On January of 2023, the U.S. FDA added sesame to the official list of major food allergens, as identified by the Food Allergen Labeling and Consumer Protection Act of 2004, that includes milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans.
The US-FDA Grants Citizen Petition on Acacia (Gum Arabic) as a Dietary Fiber
On December 17, 2021, The U.S. Food and Drug Administration (FDA) recently granted a citizen petition concerning the classification of acacia (Gum Arabic) as a dietary fiber.
US-FDA Announces New Requirements to Facilitate Export of Food Under China New Registration – Decree 248
On December 6, 2021 the FDA announced that establishments currently exporting certain food products to China to voluntarily submit information. The FDA is implementing this request in response to new facility registration requirements from China.
Registration of Imported Pet food in China
If an overseas pet feed manufacturer exports pet compound feed or pet additive premix feed to China, it shall entrust an overseas enterprise’s office in China or an agency in China to apply for registration with the agricultural administrative department of the State Council and obtain an import registration certificate in accordance with the law.
Regulatory Overview: Registration of Children’s Cosmetics in China
In China Children’s cosmetics refer to cosmetics that are suitable for children under 12 years old and have the functions of cleaning, moisturizing, body conditioning, sun protection and etc.
Brazil’s Anvisa authorizes melatonin in food supplements
The approval of Melatonin as an acceptable ingredient in food Supplements occurred through the amendment of Normative Instruction (IN) No. 28/2018,
Brazil Regulatry Breakdown: Food supplement or specific medicine?
The food supplement category was created in Brazil in 2018 to ensure the population’s access to safe and quality products. However, there is still confusion about the framing and registering the products in brazil ; is it a Food Supplement or is its a specific medicine?
An Introduction to Registration of Food Supplements in China
In China, nutrient supplements are regulated as one category under the umbrella term health food.
South korea’s MFDS announces revision of Standards and Specifications for Health Functional Food on functional ingredients
The revision strengthens safety management standards for 8 functional ingredients.
Food Supplements in Latin America : Market overview and Regulations
Latin America is becoming a land of opportunity for many emerging markets and Food Supplements are rapidly becoming more popular in the LATAM region.This blog will overview Brazil, Mexico and Argentina Market potential for food supplements and relevant regulation specific to each region.
Brazil’s Anvisa establishes New Standards on label warnings and formulas
Brazil’s Anvisa new standards require companies to warn about formula changes in products subject to health surveillance.