Legal Alert - American Herbal Products Association (AHPA)

Technical Workshops

AHPA regularly presents in-person technical workshops to train the herbal products industry on the latest tools and methods that help ensure high-quality products and compliance with federal and state regulations.

Upcoming Events

Caffeine in Food and Dietary Supplements: Examining Safety - Workshop Summary

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 to reopen comment period on the cosmetics and foods portions of its guidance on determining if human research studies require an investigational new drug application

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.

Distinguishing Liquid Dietary Supplements from Beverages

Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements

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.


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.


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

Author: Anonym

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.

Author: Anonym
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