Insights on Food, Drug, Medical Device & Cosmetic

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. 

A review of FSIS recall data from the past five years indicates that recalls of meat and poultry products due to the presence of foreign matter contamination have grown in number, particularly over the past year.

Earlier this week, the US Food and Drug Administration (FDA) issued revised food safety standards known as the “Manufactured Food Regulatory Program Standards” (MFRPS).

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.

FDA continues to maintain an aggressive enforcement stance against cosmetics/personal care product companies and has already issued a record 19 Warning Letters to such companies so far in 2016.

The US Food and Drug Administration published a Final Rule in the Federal Register on September 6, 2016, which establishes that Over-the-Counter consumer antiseptic wash products containing one of 19 specific active ingredients (listed below) can no longer be marketed.

As Congress returns from its summer recess and begins wrapping up its work for the remainder of 2016, one of the many outstanding issues is FDA regulation of cosmetics and personal care products.

Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of the Controlled Substances Act for the fifth straight time.

The Beer Institute (BI) announced last week that is was implementing a “Brewer’s Voluntary Disclosure Initiative” intended to encourage its membership to begin disclosing nutritional information about its products on product labeling, packaging and on product websites.

The House of Representatives has voted 306-117 to approve the bipartisan GMO disclosure bill to amend the Agricultural Marketing Act of 1946 and to establish a mandatory National Bioengineered Food Disclosure Standard.

Late Thursday night, the Senate voted 63-30 to approve a bipartisan GMO disclosure bill hammered out earlier by Agriculture Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI). 

Manufacturers were reminded recently why resale price maintenance policies can be risky.

FDA announced Tuesday that it will begin reevaluating how it regulates the use of the term “healthy” on food labeling.

FDA recently issued its final guidance on restaurant menu labeling intended to help restaurants and similar retail food establishments understand nutrition labeling requirements under the Federal Food, Drug, and Cosmetic Act that may apply to them.

Last week, the Department of Health and Human Services (HHS) and Department of Agriculture (USDA) released the federal government’s 2015-2020 Dietary Guidelines.

The TPP will undoubtedly increase the volume of food choices within the twelve nation pact. Congress is well aware of this anticipated increase in competition and will work to ensure that US border agencies have the resources to enforce regulations to guard against unsafe and counterfeit products.

Recently, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion issued a Warning Letter to drug maker Duchesnay, Inc., after reality TV star Kim Kardashian endorsed the company’s morning sickness drug, Diclegis, on her Instagram account.

On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs.

An Arent Fox team led by noted commercial litigator Hunter T. Carter prevailed at the US Court of Appeals for the Second Circuit.

Earlier this week, the owners of the egg distribution firm, Quality Egg, LLC (Quality Egg), were sentenced to three months in prison, given one year of supervised probation, and required to each pay a $100,000 fine after pleading guilty to selling eggs in 2010 that were contaminated with salmonella.

Last week, 14 state attorneys general sent a letter to Congress requesting that it investigate the herbal supplements industry, as well as consider giving the US Food and Drug Administration (FDA) stronger oversight authority over the marketing of such products in the US.

Recently, the US Food and Drug Administration issued a Warning Letter to L’Oreal USA for marketing its cosmetic products, “Rosalic AR Intense” and “Mela-D Pigment Control,” with claims deemed by FDA to be drug claims.

On January 28, 2015, Sen. Richard Durbin (D-IL) and Rep. Rosa DeLauro (D-CT) introduced respective companion food safety legislation in the Senate (S.287, the “Safe Food Act of 2015”) and House (HR.609).

The last decade has seen enormous growth in the human tissue products industry, following the Food and Drug Administration’s establishment, in 2001, of a tiered approach to the regulation of these products (referred to as “human cells, tissues and cell- and tissue-based products,” or “HCT/Ps”).