FDA Compliance Made Easy

[...] warning letter was prompted by the certain marketing. In particular, the Company violated the Federal Food, Drug, and Cosmetic Act by promoting the use of several products to cure, treat, mitigate, or [...]

[...] . The Federal Food, Drug, and Cosmetic Act mandates that the FDA classify medical devices into one (1) of three ( [...]

[...] was in violation of the CGMP, its products were considered “adulterated” by the FDA under the Federal Food, Drug, and Cosmetic Act. There are CGMPs for various industries, including foods, dietary [...]

[...] contains various allegations that the Company’s products are adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and FDA regulations. In particular, the Company’s [...]

[...] $21 to $31 billion in cumulative benefits to consumers over the next 20 years. As with all FDA regulations, it is important to maintain compliance with these rules to avoid adverse Agency action or [...]

[...] business must comply with under the Federal Food, Drug, and Cosmetic Act (FDCA) and other FDA regulations. You can read the article here. As the FDA explains, the Public Health Security and [...]

[...] , companies must be prepared to respond by establishing and maintaining compliance with FDA regulations. Although the Oversight Committee Report focused narrowly on drug shortages, the statistics [...]

[...] for their intended uses. Similar to foods, ingredients and labeling must be compliant with FDA regulations. Companies importing cosmetics are not required to register with the FDA but are encouraged [...]

[...] be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act. FDA may also request seizure of food products where the label of the product does not conform [...]

[...] its dietary supplements as unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). More specifically, the FDA is alleging that the company makes “ [...]

[...] by the FDA. Specifically, pursuant to Sections 201(s) and 409 of the U.S. Food, Drug, and Cosmetic Act (“FDCA”) any substance that is intentionally added to food is a food additive that [...]

[...] steroids, which makes it an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). The FDA’s announcement may be found here. Under the FDCA, as [...]

[...] regulations for “energy drinks” and publishing final guidance to help dietary supplement and beverage manufacturers determine whether a liquid food product, such as an energy drink, [...]

[...] issued an alert to consumers on the product Reumofan Plus. Purportedly marketed as a dietary supplement, Reumofan Plus is manufactured in Mexico by the company Riger Naturals. According to [...]

[...] FDCA, as amended by the Bioterrorism Act of 2002, the FDA is authorized to detain a food or dietary supplement if the agency believes that the product presents a threat of serious health consequences. [...]

[...] in dietary supplements. In sum, whether a product is properly marketed as a beverage or a dietary supplement will depend on a number of factors, including labeling, intended use, and ingredients, [...]

[...] from Operations After Ignoring FDA Warning Letter appeared first on The Law Office of Katherine Giannamore, P.A.. [...]

[...] .com The post FDA Releases Proposed Rules under FSMA appeared first on The Law Office of Katherine Giannamore, P.A.. [...]

[...] Required for Company Enjoined from Marketing Products appeared first on The Law Office of Katherine Giannamore, P.A.. [...]

[...] @giannamore-law.com. The post USDA Organic Labeling appeared first on The Law Office of Katherine Giannamore, P.A.. [...]

[...] On January 21, 2014, the U.S. Food & Drug Administration (“FDA”) issued a Statement on the Institute of Medicine’s Report (“ [...]

[...] On February 27, 2014, the U.S. Food and Drug Administration’s (“FDA”) moved to update nutrition facts labels (“Nutrition Facts [...]

[...] On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which [...]

[...] On April 11, 2014, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled “Draft Guidance for [...]

[...] (October 11, 2013). If you have any questions about medical foods, including compliance with FDA requirements, please contact us at: contact@giannamore-law.com. [...]

[...] responses thereto may be found here. If you have any questions about compliance with FDA requirements concerning the marketing of FDA-regulated products, please contact us at: contact@giannamore- [...]

[...] additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim. The regulation applies to all foods regulated by the [...]

[...] here. If you have any questions about food labeling, including compliance with FDA requirements pertaining to major food allergen labeling, please contact us at: contact@giannamore- [...]