Ladies and Gentlemen, First, allow me to give credit where credit is due. The information regarding Ms. Burkhalter comes primarily from CNN.com, but the rest is from me. Disney World may be the most magical place on Earth, but it turned into a legal nightmare for a great-grandmother with arthritis. Yesterday (May 7, 2019), a 69-year-old woman was arrested at a Disney World checkpoint in Orlando, Florida when an Orange County Deputy found CBD oil in her purse. She then spent 12 hours behind bars before being released on a $2,000 bond. Hester Jordan Burkhalter, a great-grandmother from North Carolina, began using CBD oil for her arthritis after her doctor recommended it. She even had a note from the medical professional in her purse at the time of arrest, but it didn’t matter. Burkhalter said that she had been planning on the trip for two years. “I have really bad […]Continue Reading
U.S. Food and Drug Administration (FDA) LawyersOur FDA law practice provides business owners and multi-level marketers with legal expertise to confirm they follow all FDA regulations and consumer protection laws. Whether you work in the food and beverage, healthcare or cosmetics industry, you must adhere to FDA guidelines to keep your business afloat and thriving.
Understanding FDA Regulations for BusinessesWhen formulating or marketing an item, keep in mind that the FDA examines everything from ingredients to marketing claims to labeling information to determine the “intended use” behind a product. For example, if you sell dietary supplements with claims about curing diseases, the FDA will legally classify your product as misbranded, because supplements are not FDA-approved for treating medical conditions. Our FDA attorneys analyze each item to make sure it only includes legal, accurate information with no discrepancies and that all FDA regulations are met.
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I just wanted to give you a heads up on the latest and greatest from California and some amendments to its infamous Prop 65 that are going into effect in August 2018 (less than six months). Any company with ten or more employees that operates within the state or sells products in California must provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a listed chemical in an amount exceeding established standards set forth in Prop 65’s regulations. The regulations specifying warning content that provides a safe harbor under Proposition 65 are currently in transition. Under Prop 65, consumer goods sold in California generally must provide a “clear and reasonable warning” if chemicals listed by the state as “carcinogens” or “reproductive toxicants” are present above specified limits. California amended Prop 65 warning requirements in August 2016, and the changes are scheduled to go into effect in August 2018. If you […]Continue Reading
On March 17, 2015, the FDA issued a warning letter to KIND LLC, because the labels1 and labeling2 of KIND’s products bore a variety of nutrient content claims but the products did not meet the requirements to make such claims. In particular, the FDA asserted that several of KIND’s products had an implied nutrient content claim, because they bore statements suggesting that the products may have been useful in maintaining healthy dietary practices, and those statements were made in connection with claims or statements about nutrients. Specifically, the labels of the products bore the claim “Healthy and tasty, convenient and wholesome” in connection with statements such as: “good source of fiber,” “no trans fats,” “very low sodium,” “low sodium,” “+ antioxidants,” “+ protein,” and “7g protein.” Additionally, the FDA claimed that KIND’s website stated, “There’s healthy. There’s tasty. Then there’s healthy and tasty” and “all of our snacks are pretty much […]Continue Reading
United States Department of Justice Seeks Criminal Penalties for a Man Who is Allegedly Selling Dietary Supplements Online in Violation of Prior Court Orders On July 29, 2015, the U.S. Department of Justice announced that it is pursuing criminal contempt sanctions against a Livingston, Montana, man for selling dietary supplements and drugs in violation of two court orders. Toby McAdam, 57, is alleged to have violated a 2010 court order and an order of civil contempt issued in 2013, both of which prohibit him from selling dietary supplements and drugs. The government alleges that McAdam has continued to sell both supplements and drugs, and failed to close down his business and online sites. According to documents filed today, McAdam violated the order of civil contempt by failing to shutter Internet businesses on Amazon.com, websites, and a promotional Facebook page McAdam uses to promote his products. “Court orders must be taken […]Continue Reading
Supplement Marketers Will Relinquish $1.4 Million to Settle FTC Deceptive Advertising Charges The marketers of a dietary supplement called Procera AVH will relinquish $1.4 million under settlements resolving Federal Trade Commission charges that they deceived consumers with claims that the supplement was clinically proven to significantly improve memory, mood, and other cognitive functions. Under the terms of the settlements, the defendants will pay $1 million to the FTC, and another $400,000 to satisfy a judgment in a case brought by local California law enforcement officials. They also will be barred from making similar deceptive claims in the future and from misrepresenting the existence, results, or conclusions of any scientific study. According to the FTC’s complaint, the defendants marketed and sold Procera AVH as a “solution” to memory loss and cognitive decline, including as associated with aging. The defendants advertised the product using infomercials, direct mail flyers, newspapers, and the Internet.Continue Reading