Recent regulations released by the FDA contain several provisions that are harmful to doctors, patients, and compounding pharmacists. Office Use: This is an area of the rulemaking that has garnered the biggest reaction from the compounding community. Congress and the FDA have required a patient-specific prescription for all drugs compounded, with a narrow exception if […]
Compounding has recently undergone a regulatory overhaul by Congress and the FDA. In November 2013, the Drug Quality and Security Act (DQSA) was signed in to law, amending the federal Food, Drug, and Cosmetic Act (FDCA) and overhauling the regulation of compounding. In July 2014, the FDA released rules and guidances and other documents implementing […]
Last week saw an inter-agency power grab. It begins with the weakening of organic standards—and could end with the term “organic” becoming practically meaningless. Action Alert! In September, the USDA announced changes to its interpretation of the “sunset” provision in the Organic Foods Production Act (OFPA), an incredibly important piece of legislation that Congress passed […]
Patent protection means you get to charge whatever the market will bear. In this case, it bears a 935% increase in the price tag. Xyrem is the brand name for sodium oxybate. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid, or GHB—the “date rape drug.” It’s an old drug—even older than aspirin—and it’s FDA-approved […]
…and turn supplements into drugs. What is this agency thinking? Action Alert! What the FDA does about supplements is usually complicated—we think intentionally so, in order to confuse Congress and critics. Bear with us as we try to disentangle the threads. We need to get this story out now because the FDA has just opened a […]
And if scientific research about them is published, the FDA will take them away—forever. Action Alert!
Patent protection means you get to charge whatever the market will bear. In this case, it bears a 935% increase in the price tag.
Don’t cheer yet—they’re spending all that money to get Pepsi to develop some processed food snacks for the kids! Bloomberg reports that India’s government is seeking help from an unlikely partner to improve the diets of 107 million of its hungriest children: PepsiCo. The current government has been in power for only three months, but […]
Amazing—the little “Like” button has the power to magically turn supplements into drugs. Action Alert! You will recall how the FDA threatened cherry growers and walnut producers with jail if they opened their mouths about the curative powers of these foods. Now the FDA has issued a warning letter to the Utah nutritional supplement company […]
A new lawsuit filed by a “consumer watchdog” group says most Americans are not vitamin deficient and don’t benefit from supplements. Huh? Earlier this month we told you about international pharmaceutical company Bayer AG’s battle with the Federal Trade Commission over whether its marketing statements about its probiotic colon supplement are unsubstantiated disease claims (not […]