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FDA initiates new online reporting method for dietary supplement adverse events to facilitate reporting

The U.S. Food and Drug Administration (FDA) is now accepting online submission of voluntary and mandatory dietary supplement adverse event reports.

The FDA has implemented a secure capability in the interest of efficiency and as a convenience to dietary supplement manufacturers, packers and distributors, as well as the public at large. Both mandatory and voluntary dietary supplement adverse event reports (currently the 3500A and 3500 forms, respectively) may now be submitted online.




Draft Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electroni

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

Sensa and Three Other Marketers of Fad Weight-Loss Products Settle FTC Charges in Crackdown on Deceptive Advertising

The Federal Trade Commission today announced a law enforcement initiative stopping national marketers that used deceptive advertising claims to peddle fad weight- loss products, from food additives and skin cream to dietary supplements

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?

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