Newsletter - September 17, 2015
Food Safety Comes to Fore with New FDA Rules for GMP
More than 48 million people (1 in 6 Americans) get food poisoning every year because of contaminated or poor quality food. Foodborne diseases are responsible for about 128,000 hospitalizations and 3000 deaths, many of them infants and children. In Jan 2011, the US Congress FDA passed the Food Safety Modernization Act (FSMA), which gave FDA mandate to create strict GMP requirements for food manufacturers. Under the FSMA, FDA announced it will implement four new rules and three Guidance documents to create mandatory preventive controls at food facilities and mandatory standards for all food manufacturers. Read More...
FDA Blocks Four New Cigarette Brands from the Makers of Camel®
Since the passage of Tobacco Control Act in 2009, the FDA has slowly built rules to regulate all forms or tobacco products, from ethnic Bidis to electronic cigarettes. FDA has released 16 rules to date that cover in details the current regulations. Under the Tobacco Control Act, FDA was given seemingly limited powers to assure that the tobacco industry is transparent on the quality of its products, it is visible and vocal about the risk of smoking, and it does its best to avoid tobacco use by youth. One rule, called the “substantially equivalence” rule requires that any new tobacco product introduced in the US market after 15 February 2007 meet either of two requirements; Read More...
FTC Wants FDA to Increase Regulation of Homeopathic Drugs
When a non-prescription drug is primarily sold over-the-counter (OTC) and online, the primary regulatory agency is Federal Trade Commission (FTC) and not FDA. FTC monitors advertisement of such products and regulates them under false promotion laws to assure that marketing of such products does not claim more than it should. FTC appealed to FDA to apply same rules as OTC drugs to homeopathic drugs. Homeopathic products form a special category of OTC products. Any drug manufactured per the Homoeopathic Pharmacopoeia of the United States (HPUS) is allowed in the US market. In 1970s, when FDA created rules for OTC drugs, it did not review homeopathic drugs recognizing their unique status as OTC drugs that we used under supervision of a homeopathic doctor. Read More...
Food Safety Comes to Fore with New FDA Rules for GMP
More than 48 million people (1 in 6 Americans) get food poisoning every year because of contaminated or poor quality food. Foodborne diseases are responsible for about 128,000 hospitalizations and 3000 deaths, many of them infants and children. In Jan 2011, the US Congress FDA passed the Food Safety Modernization Act (FSMA), which gave FDA mandate to create strict GMP requirements for food manufacturers. Under the FSMA, FDA announced it will implement four new rules and three Guidance documents to create mandatory preventive controls at food facilities and mandatory standards for all food manufacturers. Read More...
FDA Blocks Four New Cigarette Brands from the Makers of Camel®
Since the passage of Tobacco Control Act in 2009, the FDA has slowly built rules to regulate all forms or tobacco products, from ethnic Bidis to electronic cigarettes. FDA has released 16 rules to date that cover in details the current regulations. Under the Tobacco Control Act, FDA was given seemingly limited powers to assure that the tobacco industry is transparent on the quality of its products, it is visible and vocal about the risk of smoking, and it does its best to avoid tobacco use by youth. One rule, called the “substantially equivalence” rule requires that any new tobacco product introduced in the US market after 15 February 2007 meet either of two requirements; Read More...
FTC Wants FDA to Increase Regulation of Homeopathic Drugs
When a non-prescription drug is primarily sold over-the-counter (OTC) and online, the primary regulatory agency is Federal Trade Commission (FTC) and not FDA. FTC monitors advertisement of such products and regulates them under false promotion laws to assure that marketing of such products does not claim more than it should. FTC appealed to FDA to apply same rules as OTC drugs to homeopathic drugs. Homeopathic products form a special category of OTC products. Any drug manufactured per the Homoeopathic Pharmacopoeia of the United States (HPUS) is allowed in the US market. In 1970s, when FDA created rules for OTC drugs, it did not review homeopathic drugs recognizing their unique status as OTC drugs that we used under supervision of a homeopathic doctor. Read More...
