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News from the FDA
Content Labeling Requirements Changed for Certain OTC Drug Ingredients
New rules were published on March 24 requiring content labeling (amount present per dosage unit, eg, tablet) and warning labeling for over-the-counter drugs that contain levels of calcium, magnesium, sodium, or potassium that might be harmful to people with certain underlying medical conditions. Mouth rinses, fluoride toothpastes and mouth washes are not covered by this regulation. Under the new rules, the labeling of oral OTC drugs containing sodium, calcium, magnesium or potassium must state the amount of a particular ingredient in each dose if they contain: 1) 5 mg or more of sodium in a single dose; 2) 20 mg or more of calcium in a single dose; 3) 8 mg or more of magnesium in a single dose; or 4) 5 mg or more of potassium in a single dose. The new rules also require new warnings on the label to alert people with kidney stones, decreased kidney function due to kidney disease, or people who are on sodium-, calcium-, magnesium-, or potassium-restricted diets to consult their doctors before using products for oral ingestion that contain more than: 1) 140 mg of sodium as the maximum daily dose; 2) 3.2 grams of calcium as the maximum daily dose; 3) 600 mg of magnesium as the maximum daily dose; or 4) 975 mg potassium as the maximum daily dose. The effective date of these rules was April 23.
Warning Letters Sent over False Weight-Loss Claims
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?