Tag Archives: DRUGS

FDA Approves Drug to Treat Peanut Allergy in Children

On January 31, FDA approved the first drug to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. The drug, Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] may be given to individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy. However, FDA warns that those who take Palforzia … Continue Reading

FDA and FTC Send Warning Letter for Marketing Unapproved Drugs and Dietary Supplements Containing CBD

On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions. As described in the … Continue Reading

A Look at the Food Handler Antiseptic OTC Rulemaking

On December 7, 2018, the Food and Drug Administration (FDA) established a docket and requested data, information, and comments to “assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter (OTC) human use.”  The request … Continue Reading

FDA Finds High Levels of Heavy Metals in Kratom Products

In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, … Continue Reading

FDA Action Against Dietary Supplements Containing Tianeptine Signals Renewed Focus on Protecting Consumers from Dietary Supplements with Unauthorized Drug Claims

  The Dietary Supplement Health and Education Act of 1993 (DSHEA) was intended to provide a framework for FDA to regulate dietary supplements.  DSHEA established a new category of permitted claims for dietary supplements called “statements of nutritional support.”  Claims of mitigating or treating a disease, however, are “drug claims” and are not permitted on … Continue Reading

FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers

In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there … Continue Reading

FDA Commissioner Gottlieb Issues Statement On Advancing the Science and Regulation of Live Microbiome-Based Products

FDA Commissioner Scott Gottlieb, MD, issued a statement on August 16 regarding the role of microorganisms on health.  Dr. Gottlieb provided background on the use and regulatory status of microorganisms. Also in his statement, Commissioner Gottlieb provided the underlying rationale for his statement via the example of probiotics administered to premature infants as a preventive … Continue Reading

FDA Launches “Organ Chip” Project to Support Food and Dietary Supplement Safety Research

“Organs-on-Chips” technology has been the focus of a public-private collaboration between FDA, the federal Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).  “Organs-on-Chips” essentially involves creating miniature-sized human organ systems on micro-engineered chips about the size of an AA battery.  This technology has revolutionized the manner in which scientists can study the … Continue Reading

E-Commerce Enforcement

FDA takes significant action to stop illegal drug sales online. FDA has broad regulatory authority over the marketing of food, drugs, medical devices, and cosmetics in the U.S.  Although many of the Agency’s enforcement actions target physical facilities and products on shelves, FDA also has authority over e-commerce, i.e., the significant sales of FDA-regulated products … Continue Reading

Pharma and the First Amendment

Amarin settlement paves way for “off-label” promotion of omega-3 product. As previously covered on this blog, the pharmaceutical industry has been awaiting the resolution of the groundbreaking Amarin case.  At the heart of the case is Amarin’s marketing of Vascepa, an omega-3 drug product, as effective in treating patients with “persistently high” triglyceride levels, as compared to … Continue Reading

Chicken Out

FDA approves transgenic chicken, but not for consumption. FDA has the authority to approve genetically modified (GM) animals as “new animal drugs.”  In 2009, FDA approved a GM goat — the ATryn Goat — that produces a therapeutic biologic in its milk.  In November 2015, FDA approved its first-ever GM animal intended for direct human consumption — the … Continue Reading

Fish Oil and the First Amendment

Federal court ruling paves the way for off-label promotion of fish oil product. FDA’s historical position is that “off-label promotion” — the promotion of pharmaceutical products for unapproved uses — violates the Federal Food, Drug, and Cosmetic Act.  The underlying logic is that:  (1) drugs are misbranded when they fail to bear adequate directions for … Continue Reading

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