FDA Challenges Dietary Supplement Makers on Marketing of DMAA Products

• By: Staff Editor
• Date: July 13, 2012

The FDA, which regulates dietary supplement products and their ingredients, recently warned manufacturers of dietary supplements containing DMAA (1, 3-dimethylamylamine) for not providing evidence regarding safety of their products. The Agency thus deemed the products as ‘adulterated’ (as DMAA is known to cause serious side-effects) and sent warning letters to 10 manufacturing firms for failing to demonstrate the safety of their products.

According to the experts from FDA’s Dietary Supplement Program, manufacturers should submit evidence regarding safety of their products prior to marketing, a rule which some firms clearly violated. They also pointed that they have received 42 adverse event reports on DMAA products (even though other accompanying conditions like cardiac disorders, nervous system disorders, psychiatric disorders can cause such events and cannot be ruled out ) and that DMAA can result in serious side-effects like narrowing of blood vessels and arteries and can further trigger the occurrence of cardiovascular events.

Warning letters sent to some firms for violating regulations:
 

DMAA also known as 1, 3-dimethylamylamine is known to be a natural stimulant and a ‘workout booster’ used in dietary supplements.
 

The FDA issued warning letters to ten manufacturers and distributors of supplements containing DMAA (dimethylamylamine products) for illegally marketing products for which safety data has not been reported to the Agency. Manufacturers who received such letters failed to submit a notification before marketing their products and did not have established safety records. This followed notifications being sent to the distributors by the U.S Defence Department, which was investigating to confirm whether products containing DMAA played a role in causing fatal health events.

The Agency suggested that the companies:

• halt marketing their products
• respond by submitting an NDI notification within a period of 15 days
• implement necessary changes to address the issues in the warning letters
• provide evidence to support their conclusion that DMAA is a safe supplement ingredient

The agency also made the following points:

• Not a dietary ingredient: The FDA cited that synthetic form of DMAA cannot be considered as a “dietary ingredient” and that such products are new dietary ingredients (NDIs) that are illegally on the market so, cannot be used as active ingredients in the production process.
• Need to follow NDI process: The FDA clearly stated that in order to market any ingredient, evidence is required that the constituent has been marketed before or the ingredient has to follow the NDI process and guidelines.
• Unaware of safety: The FDA further pointed out that it is unaware of evidence or history of use to indicate that these products are safe for consumers, so manufacturers and distributors were marketing unapproved products for which requirements had not been met.

Reaction of product marketers
 

• Marketers of the product opined that they are unaware of any scientific or clinical evidence which challenges the safety of their products and that DMAA is legally marketed as per federal law and regulations.
• Some companies have even put forth that they have supporting evidence to prove that DMAA is both safe and a legitimate dietary ingredient and has even been in the food supply in the form of geranium oil.

A brief summary of FDA’s new dietary ingredient notification
 

• According to FDA regulations, dietary supplement manufacturers who make use of ingredients, not marketed in a dietary supplement prior to October 15, 1994 should report evidence in order to support the safety and efficacy aspects of New Dietary Ingredients (NDIs).
• NDI Draft Guidance states that - a synthetic version of a compound found in a botanical cannot be considered as a dietary ingredient.
• Manufacturers should file NDI notifications which need to be submitted before marketing products (within 75 days) for the use of DMAA as a New Dietary Ingredient (NDI) to the FDA.
• According to ‘Dietary Supplement Health and Education Act’ manufacturers of dietary supplements should ensure that they are marketing a safe product. The safety and efficacy aspects should be considered prior to marketing.
• All serious adverse event reports associated with use of the dietary supplements should be submitted to the Agency by the manufacturer, packer, or distributor whose name appears on the labels of dietary supplements marketed in the U.S.
• Manufacturers need not register their products before producing or selling but must ensure that dietary product label information is clinically true and not misleading.
• Companies which manufacture, package, label or hold dietary supplements along with those involved with testing, quality control, and distribution should follow the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control.