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Department of Health and Human Services letter to California and New Jersey federal courts

Dear Judges Gonzalez Rogers, White and McNulty:

This letter responds to your Orders issued on July 11, July 25 and November 1, 2013 respectively, in the above-referenced cases, which referred to the question of whether food products containing ingredients produced using bioengineered ingredients may be labeled "Natural" or "All Natural" or "100% Natural" to the Food and Drug Administration ("FDA" or "agency") for an administrative determination under 21 C.F.R. § 10.25 (c). In those cases, the plaintiffs allege that the "Natural," "All Natural," and/or "100% Natural" labeling on the Defendants' products are misleading because the products contain corn grown from bioengineered, genetically modified seeds. ...

Can a Dietary Supplement Treat a Concussion? No

Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).

The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms-the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.

GMO labeling: What we can learn from organic labeling

Washington state voters rejected Initiative Measure Number 522 on Nov. 5, which would have required food labels-presumably including dietary supplement labels-to disclose any ingredients derived from genetically engineered plants or animals (also referred to as genetically modified organisms, or GMOs).

Monster Beverage Corporation responds to paper on energy drinks and heart function

CORONA, Calif., Dec. 2, 2013 /PRNewswire/ --Monster Beverage Corporation (Nasdaq:MNST) today released the following statement in response to a paper presented at the Radiological Society of North America's annual meeting entitled "Caffeine and Taurine Containing Energy Drink Improves Systolic Left-ventricular Contractility in Healthy Volunteers Assessed by Strain Analysis Using Cardiac Magnetic Resonance Tagging":

U.S. Marshals seize more than $2 million in adulterated dietary supplements from Georgia company

FDA acts to prevent distribution of products containing unapproved food additive

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent. The retail value of the seized

FDA: Botanical Compounds May Not be Legal Dietary Ingredients

Just because a compound is found in a botanical doesn't mean FDA considers it a part of the food supply, according to Daniel Fabricant, Ph.D., Director, Division of Dietary Supplements, FDA, during his featured presentation at SupplySide West. Thus, if a supplement company introduces an isolated botanical substance to the market without submitting a new dietary ingredient (NDI) notification, the agency is likely to consider it an adulterated product.

Timing right for federal standard on GMO: AHPA

With more than 85% of the votes in on Washington State's GMO labeling initiative 522 as of Thursday night, it appears that the Yes side has an insurmountable deficit to overcome, getting 47% of votes to the No side's 53%. (Due to the state's unique mail-in voting system, the outcome may not be clear until this weekend.) So what now?

FTC Charges HCG Marketer with Deceptive Advertising

Defendants Promised Dietary Supplement Would Cause Substantial Weight Loss
The Federal Trade Commission has sued an Arizona man who markets HCG Platinum diet products by falsely claiming the products will cause consumers to lose substantial amounts of weight. Kevin Wright and his companies must respond to the complaint in federal court.

 

AHPA Calls for Withdrawal of "Hugely Flawed" NDI Notification Guidance in Comments to FDA

AHPA requests FDA to issue new guidance

The American Herbal Products Association (AHPA), in comments filed with the Food and Drug Administration (FDA), called for the agency to withdraw what it called the "hugely flawed" "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues."

Shelf Life Dating of Botanical Supplement Ingredients and Products

Overview of federal regulations and compliance strategies

This document provides an overview of federal regulations regarding the use of shelf life dates for dietary ingredients and dietary supplements sold in the United States, with a particular emphasis on botanical ingredients and products. In addition it presents various strategies for meeting those requirements.
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