AHPA Alerts

Caffeine, a central nervous stimulant, is arguably the most ingested pharmacologically active substance in the world. As it occurs naturally in more than 60 plants, caffeine has been part of many cultures for centuries. But the caffeine-in-food landscape is quickly changing.

FDA has decided to reopen, for 60 days, the comment period for specific portions of its final guidance for clinical investigators, sponsors, and institutional review boards (IRBs), entitled "Investigational New Drug Applications (INDs) -- Determining Whether Human Research Studies Can Be Conducted Without an IND," which was announced in the September 10, 2013 Federal Register.   FDA will reopen the comment period only for subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).  The Agency is taking this action in response to requests that it provide an additional opportunity to submit comments on these portions of the guidance.

Four U.S. lawmakers joined with more than 200 food companies, organic farming groups, health and environment organizations and other groups on Thursday to urge President Barack Obama to require manufacturers to label food products that contain genetically engineered ingredients.

I. Introduction
We are issuing this guidance to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage. This guidance describes the factors that distinguish liquid products that are dietary supplements from those that are conventional foods.  Further, this guidance reminds manufacturers and distributors of dietary supplements and beverages about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding their respective ingredients and labeling.

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.

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic.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.

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

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. ...

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.

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).