Legalities
What Did I Agree To? Purchase Order Transactions
Supply chain disputes come in a multitude of varieties. They may arise between brands, ingredient suppliers, manufacturers, distributors or retailers and can occur in a variety of contexts. The one constant in almost all supply chain disputes is that an “agreement” governs the dispute. What that agreement is, however, is not always as straightforward as ...
Managing An FDA Inspection: Making The Most of Your Chance to Put Things on Track From The Get-go
A primer for dietary supplement manufacturers, own brand distributors and ingredient suppliers. While the truism “You never get a second chance to make a first impression” has been attributed to both Will Rogers and Oscar Wilde, it is rarely disputed that that an initial encounter sets the tone for all future interactions and that it ...
Checking on Supplements: NAD’s Recent Guidance on Substantiating Ingredient vs. Product Claims
Imagine a breakthrough dietary supplement that solves all your problems—you’ll lose weight, feel calm and relaxed, reduce bloating, sleep better, wake up happier and have more energy. Sound too good to be true? Maybe. But what if studies show that the ingredients in the supplement each support those claims—would that be false advertising? On Aug. ...
Investigating Quality Incidents
Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex processes involved in making a dietary supplement can occur because human beings are not perfect. These events can range from ...
Aggressively Defending the Baseless Class Action
By all accounts, consumer class action filings have dramatically increased over the past few years. And for every class action that gets filed, there are dozens, if not hundreds, of threatened claims. Most threatened claims are confidentially settled individually on an out-of-court basis, with little regard to the strength or weakness of the claims being ...
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 ...
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