Legalities
FDA GMP Inspections Return to Pre-COVID Levels
Supplement industry compliance struggles remain. Data recently released by FDA (U.S. Food and Drug Administration) indicates that for the second year in a row, the number of dietary supplement current good manufacturing practices (cGMP) related inspections of dietary facilities remains steady following a severe decline in 2020 and 2021 because of the global pandemic. Consistent ...
Navigating A Product Recall—Don’t Be Scared, Be Prepared
A product recall can be one of the most traumatic events in any company’s history. Recalls involve contacting customers and perhaps even the public at large and telling them that something has gone wrong with your product(s), that they need to stop using/eating the effected product, and that it needs to be returned to you ...
So, You Received a Demand Letter
Sometimes it’s fun checking the mail. Sometimes it isn’t. Like other industries, companies operating in the hyper-competitive natural products space may receive, from time to time, a demand letter from an attorney, outlining a purported legal claim by a consumer or competitor. While there is no immunity from such letters, knowledge is power and can ...
Modernization of Cosmetics Regulation Act of 2022
FDA Will Have Extensive Authority to Regulate Cosmetics Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321(i), “cosmetics” are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance ...
Trademark and Brand Protection Strategies: United States and Abroad
A trademark is a word, symbol or phrase (or even a smell or sound) that is used to distinguish the source of goods and services on the market from every other brand out there. As opposed to copyright or patent rights which expire, trademarks can last in perpetuity if properly maintained. This provides enduring value ...
Has your Company Been the Victim of a Consumer Class Action?
I was extremely happy to attend my first SupplySide West, an event I normally never miss, in three years, due to COVID-19. The show presents a wonderful opportunity to speak with leaders in the natural products industry and gauge what is going on in the trade. As an attorney, it seemed that many people I ...
Trademarks and CBD: How Can Nutraceutical Companies Protect Trademarks Used on Products Containing CBD?
Discussion of the current policy of the U.S. Patent and Trademark Office, recent legal decisions and strategies for obtaining protection for marks used in connection with products containing CBD. The legalization of hemp-based cannabis products by the United States Congress in 2018 was a major step forward in the development of the cannabis industry. Unfortunately, ...
FDA’s Misguided NDI Amnesty Scheme—But Companies Should Still Comply with the Law
On May 19, 2020, FDA (U.S. Food and Drug Administration) published a proposed Guidance Document announcing its intention to adopt a “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification: Guidance for Industry” (The Draft Guidance). This document announced FDA’s intent to consider, pending public comment, a six ...
Is It Time to Update Your Website Terms?
Today, virtually every business is an e-business. Whether a business’ website looks much like it did when it was launched 10 years ago or has recently been updated to an e-platform offering the latest interactive tools, websites are often the first and best method of educating consumers about the business and its products and services. ...
New Enforcement and New Rules for Made in USA Claims
On July 1, 2021, FTC (U.S. Food and Trade Commission) finalized its proposed “Made in USA” Rule, in an effort to “crack down” on false and unqualified claims by companies that their products are Made in the USA. The rule was published on July 14, 2021 in the Federal Register and became effective on Aug. ...
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