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Legal Alerts

District Court enters permanent injunction against California firm for alleged cGMP violations (DOJ)

The Justice Department announced today that U.S. District Court Judge Otis D. Wright II of the Central District of California entered a consent decree of permanent injunction against GM Manufacturing Inc. (GMM) and Mao L. Yang, Mary Chen and David Yang on Friday, June 20, 2014, to prevent the distribution of adulterated dietary supplements.

FTC sues marketers of Green Coffee Extract (FTC)

The Federal Trade Commission has sued a Florida-based operation that capitalized on the green coffee diet fad by using bogus weight loss claims and fake news websites to market the dietary supplement Pure Green Coffee. Popularized on the syndicated talk show The Dr. Oz Show, green coffee bean extract was touted as a potent weight loss treatment that supposedly burns fat.

Recent FDA enforcement actions against illegal, tainted products masquerading as dietary

FDA issues draft guidance for honey labeling (FDA)

Recent FDA enforcement actions against illegal, tainted products masquerading as dietary supplements since February 21, 2014 (FDA

Since February 21, 2014, the Food and Drug Administration (FDA) has performed four enforcement actions advising consumers not to purchase or use products because FDA laboratory analysis confirmed that these products contain undeclared ingredients.

FDA announced that SNI National is voluntarily recalling all kratom products

 The products are packaged in clamshell, zip sealed packets and green pill bottles, 4, 10, 20, and 40 count. The products can be identified by their bright green packaging and label which states that it contains Kratom. The products were sold to wholesale distributors in the following states: Alabama, California, Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts, and Ohio. The products were further distributed by those entities. SNI National has completely terminated distribution.

Legal Alert

Since January 24, 2014, the Food and Drug Administration (FDA) has performed 16 enforcement actions advising consumers not to purchase or use products because FDA laboratory analysis confirmed that these products contain undeclared ingredients.

FDA statement on Generally Recognized as Safe determinations

On March 11, 2014, Senomyx, Inc. issued a public statement suggesting that its food ingredient Sweetmyx (also known as S617) was generally recognized as safe (GRAS). The statement appeared to suggest that the U.S. Food and Drug Administration (FDA) had made the GRAS determination. In fact, the agency had not made this determination nor had it been notified by Senomyx regarding a GRAS determination for this food ingredient. The  company's statement has been corrected and now notes that a third party organization made the determination.

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.

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