FDA

DMBA in Dietary Supplements by Sebastian MELCHOR

DMBA is labeled as a dietary ingredient in some products marketed as dietary supplements. However, the FDA is not aware of any information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. As a result, for dietary supplements that contain DMBA to be lawfully marketed, one of the following must apply:

  1. the product containing the dietary ingredient must contain only dietary ingredients that have been present in the food supply as an article used in food in a form in which the food has not been chemically altered, or 
  2. there must be a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended in the product labeling, will reasonably be expected to be safe; and prior to bringing the products to market, the manufacturer or distributor must notify FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably expected to be safe.

Because neither of these conditions has been met by those marketing products that contain or are labeled as containing DMBA as a dietary ingredient, the FDA considers these dietary supplements to be adulterated.

DMBA is also known as:

  • 1,3-Dimethylbutylamine
  • 2-Amino-4-Methylpentane Citrate
  • 4-Amino-2-Methylpentane Citrate
  • 4-Amino Methylpentane Citrate
  • Amperall
  • AMP
  • AMP Citrate
  • 4-AMP Citrate
  • 4-Methyl-2-Pentanamine

FDA Encourages Comments to Help Update Food Ingredient Safety Assessment (Redbook) by Sebastian MELCHOR

April 13, 2015

The U.S. Food and Drug Administration has begun the process of updating its current guidance on food ingredient safety assessment, commonly referred to as the Redbook, and is requesting input from the public.

The agency is interested in developing a framework that incorporates the assessment of ingredients present in various products regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Examples include food additives, food contact substances, ingredients that are generally regarded as safe (GRAS), new plant varieties, dietary supplements and new dietary ingredients, cosmetic ingredients, as well as unavoidable chemical contaminants other than microbial pathogens. 

The FDA is particularly interested in comments on:

  • Which parts of the Redbook should be updated, and how FDA should prioritize updates.
  • The scope of the revised guidance, and what other guidance documents could be addressed or incorporated by reference.
  • New assays, test methods, and endpoints that could be useful for safety assessment, with justifications for why and how these proposed new methods should be considered.
  • Key studies and considerations for study interpretation for each of the regulatory categories of food and cosmetic ingredients and chemical contaminants overseen by CFSAN.
  • Ways to make the guidance more useful to stakeholders.
  • Ways to make our processes and criteria for safety assessment clearer to stakeholders.

Specific examples, precise wording, or other clear and direct suggestions that address these issues are particularly welcome.

To submit comments electronically to the docket, visit http://www.regulations.gov and enter FDA-2014-N-1497 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-1497 on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

The comment period ends on May 11, 2015.

For more information