Virginia (202) 466-6937 | Arizona (602) 388-8899

FDA to Supplement Manufacturers: Confirm Safety of Direct Food Additive or GRAS NDIs

FDA recommends that dietary supplement manufacturers and distributors voluntarily consult with it concerning the safety of supplements containing high amounts of new dietary ingredients (“NDIs”) that are approved direct food additives or GRAS. An NDI notification must be submitted to FDA at least 75 days before selling a dietary supplement if the dietary supplement contains […]

FDA Budget Sequestration

By Jonathan W. Emord Under the Budget Control Act of 2011, Congress must either agree to spending cuts or a 7.8% across-the-board cut will be imposed on all federal agencies.  With the White House and Congressional Republicans at an impasse, those automatic cuts appear likely.  For the FDA, that means a reduction in about $68 […]

Dietary Supplement Distributors are Responsible for Contract Manufacturer’s CGMP Compliance

A dietary supplement distributor that uses a contract manufacturer to make its dietary supplement can be held liable for the contract manufacturer’s failure to comply with current good manufacturing practices (“CGMPs”).   Accordingly, distributors should ensure that their contract manufacturers follow CGMPs. According to the CGMP final rule,  a company must only “comply with the CGMP […]

Government Pre-Trial Enforcement Options Against Pyramid and Ponzi Schemes

By Lou Caputo As explained in the last post, there are inherent, albeit sometimes narrow, differences between those MLM’s that truly operate as legitimate businesses and others that do not.  Depending on the circumstances, a business under federal investigation may become financially and functionally paralyzed as a result of the seizure and subsequent forfeiture of the […]

Why FTC CID’s Must Be Reformed

By Jonathan W. Emord When the Federal Trade Commission commences a non-public investigation of a company it suspects of deceptive health benefit advertising, it oftentimes resorts to use of a civil investigative demand, which is an administrative subpoena.  The Supreme Court has upheld sweeping use of investigative powers by the federal government prior to the […]

Supreme Court to Decide Whether Patent Exhaustion Doctrine Applies to GMOs, Self-Replicating Products

One of the cases the U.S. Supreme Court will decide next year is the David and Goliath like suit between an Indiana soy bean farmer, Vernon Bowman, and Monsanto Co., the producer of seeds that are genetically engineered to be resistant to glyphosate based herbicides, including Monsanto’s Roundup.   Farmers that plant Roundup Ready® crops can […]

The FDA’s and FTC’s Reliance On Randomized Clinical Trials For Dietary Ingredients Is Impractical and Unethical

The FDA and FTC intend to require randomized clinical trials (RCTs) in support of promotional claims for dietary supplements and dietary ingredients.  That much is clear.  The FTC took that position in the recent POM Wonderful case, and the FDA memorialized that position in its Evidence Based Review System (EBRS).  In practice, the FDA will […]

Due Diligence Avoids Costly Legal Fees: The Significance of Trademark Registration

All too often companies choose a name or brand for products without performing a detailed trademark search to discern if that name is already subject to a mark used in commerce.  Those companies may have few options if later sued by a competitor with a prior registration.  Registering a trademark with the United States Patent […]

The Difference Between MLMs, Pyramids, and Ponzis

By Lou Caputo Legal debate centers on whether certain multi-level marketing (“MLM”) business structures are legitimate or fraudulent.  The Sixth Circuit has explained that no definitive boundary “separates illegal pyramid schemes from legitimate multilevel marketing programs; to differentiate the two, regulators evaluate the marketing strategy (e.g., emphasis on recruitment versus sales) and the percent of […]

Jonathan Emord Nominated for WEGO Health Activist Award

We received word today that the President of Emord & Associates, Jonathan W. Emord, has been nominated for the prestigious 2012 WEGO Health Activist Award.  Many of you are aware of his achievements for health freedom.  You may not know that in addition to defeating FDA censorship on health claims 8 times in federal court, […]

Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.

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