| 2004N-0454 - Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Reopening of Comment Period|
|FDA Comment Number :||EC72|
|Submitter :||Mrs. Ellen Dee Wallace||Date & Time:||01/19/2005 01:01:25|
|Organization :||Wellness Solutions Associates|
|Dietary Supplement Industry|
| Re: Docket 2004N-0454
DSHEA (the Dietary Supplement Health Education Act) guarantees my ability to choose a wide-range of dietary supplements and ensures the FDA regulates these products appropriately - as foods, not as food additives or drugs.
I urge you to ensure that any new FDA guidelines for New Dietary Ingredients reflect the intent of Congress and continue to provide complete access to the safe, affordable and innovative dietary supplements I rely on for my health.
Recall that 2.5 million concerned consumers contacted Congress between 1992 and 1994 to support DSHEA and assure access to their supplements. In response, Congress passed DSHEA and deliberately created new and different regulations for dietary supplements. Congress enacted DSHEA to stop the FDA from treating dietary supplements like food additives or drugs and to protect consumer's rights to purchase these products.
I applaud the FDA's initiatives to fully implement DSHEA and to develop clear guidelines for manufacturers to follow when introducing new ingredients to the market, but I'm concerned that the questions FDA poses in their draft comments may lead to barriers that may preclude many safe products from reaching the market place.
Specifically, I am concerned about any new guidelines that require onerous food additive and drug like notifications for new ingredients. Given that FDA has a history of such actions, please do not create new guidelines that will require excessive testing and documentation, making the introduction of new products unnecessarily expensive. This will assuredly lead to the reduction of many products that can benefit the health of Americans and reduce the cost of health care. These actions are counter to the intent of DSHEA and consumer health interests.
Most supplement manufacturers are small businesses that will be especially hard hit by demanding notification requirements. As a result, many new products will never make it to market, and many companies in this vital section of the health market will not be able to compete. Please ensure that any new guidelines take the unique situation of small businesses into account.
Congress created the New Dietary Ingredient clause of DSHEA to serve as a gatekeeper, to keep potentially dangerous substances unknown to the human food supply off the market. This clause is not intended to create burdens for safe products that are not a threat to human health.
I am heartened by FDA's recent initiatives to fully implement DSHEA but any changes to the way FDA interprets and implements DSHEA must remain true to congressional intent. I implore the agency to use a transparent and participatory process with multiple public meetings and ample
| time for community comment to develop guidelines that are sound, reasonable and consumer focused.
Supplements provide a low cost, natural alternative to help consumers maintain their good health. The creation of any new standard that will undermine that intent will constitute an injustice to the American people.
Thank You for your assistance.