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Chinese herbal therapy debuts at Cleveland Clinic, University Hospitals

Changes made to state laws have opened the door for certified herbal therapists to prescribe custom Chinese herbal therapy blends and traditional formulas to patients within a clinical practice.

Import Alert 54-15

Reason for Alert:   FDA has seen an increase in the number of shipments of dietary supplements and bulk dietary ingredients that are, or contain kratom, also known as Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang. These shipments of kratom have come in a variety of forms, including capsules, whole leaves, processed leaves, leaf resins, leaf extracts, powdered leaves, and bulk liquids made of leaf extracts. Importers' websites have sometimes contained information about how their products are used.

Over-The-Counter Drug Monograph System-Past, Present, and Future; Public Hearing

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on the Over-The-Counter (OTC) Drug Review (sometimes referred to as the OTC Monograph Process, OTC Monograph, or OTC Drug Review). The Agency would like input on how to improve or alter the current OTC Monograph Process for reviewing nonprescription drugs (sometimes referred to as OTC drugs) marketed under the OTC Drug Review. This public hearing is being held to obtain information and comments from the public on the strengths and weaknesses of the current OTC Monograph Process, and to obtain and discuss ideas about modifications or alternatives to this process.

FSMA Proposed Rule on Sanitary Transportation of Human and Animal Food


The FDA's proposed rule would require those who transport food to use sanitary transportation practices to ensure the safety of food.

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.

Organic food and farm groups ask Obama to require GMO food labels

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.

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.

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