The following is a reply to a question regarding ATTEND and its NDC number with the FDA. The reply is from Daniel Giddens, Customer Service Supervisor for VAXA International. We hope that it may serve to answer some of your questions regarding Attend and its status with the FDA. - ed
Attend is a recognized as an alternative to pharmaceutical ADHD medications and has been available since 1987. Although Attend is not FDA approved (due to it being a natural product) it contains Homeopathics and is therefore recognized by the United States government as an Over the Counter medication (OTC). Due to this we have been assigned an NDC# (National Drug Control) for Attend; that NDC# is 67514-0266-3.
In order to verify the NDC # you must contact the FDA directly and tell them it is for a Homeopathic. There website will not list anything other than Pharmaceutical medications (ed.note - at this time the database seems to have only medications for diabetes treatment) which is why calling direct is important.
U.S. Food and Drug Administration (FDA)
Web site: www.fda.gov
Toll-free: 1-888-INFO-FDA (1-888-463-6332)
Address: 5600 Fishers Lane, Rockville, MD 20857
Because of their long use in the United States, the U.S. Congress passed a law in 1938 declaring that homeopathic remedies are to be regulated by the FDA in the same manner as nonprescription, over-the-counter (OTC) drugs, which means that they can be purchased without a physician's prescription. Today, although conventional prescription drugs and new OTC drugs must undergo thorough testing and review by the FDA for safety and effectiveness before they can be sold, this requirement does not apply to homeopathic remedies.
Remedies are required to meet certain legal standards for strength, quality, purity, and packaging. In 1988, the FDA required that all homeopathic remedies list the indications for their use (i.e., the medical problems to be treated) on the label.
The FDA also requires the label to list ingredients, dilutions, and instructions for safe use.
The guidelines for homeopathic remedies are found in an official guide, the Homeopathic Pharmacopoeia of the United States. The Pharmacopoeia also includes provisions for testing new remedies and verifying their clinical effectiveness. Remedies on the market before 1962 have been accepted into the Homeopathic Pharmacopoeia of the United States based on historical use, rather than scientific evidence from clinical trials.
Vaxa International meets all standards for manufacturing and production practices set forth by the FDA, which includes having an FDA attorney, and using a GMP Certified ‘A-Rated’ lab.
The Natural Products Association (formerly NNFA) praised President Bush's signing into law the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the "AER bill"), S. 3546. The legislation, which had cleared the 109th Congress in its final hours, will amend the federal Food, Drug and Cosmetic Act to require the reporting of "serious" adverse events for both over-the-counter (OTC) drugs and dietary supplements to the U.S. Food and Drug Administration.
The bill was overwhelmingly supported by dietary supplement retailers, and suppliers who welcomed its passage as further proof that the industry is well-regulated and committed to consumer safety. "Our top priority is providing the products that people want to lead healthier, more fulfilling lives," said David Taylor, president of the Natural Products Association. "So we welcome and support reasonable legislation like this because it will help consumers and the public understand what we have known for some time -- that our industry is made up of good people who make good products and stand by them."
The bipartisan legislation was introduced in the Senate in June of this year by Sens. Orrin Hatch (R-Utah), Tom Harkin (D-Iowa) and Richard Durbin (D-Ill.) and includes several provisions that were instrumental in earning the Natural Products Association's support. Among these key provisions are those requiring that only serious adverse events, not just any complaint, be reported; exempting retail stores from reporting directly to the FDA and preempting a potential patchwork of state laws on the issue.
"The industry has long supported passing this legislation and views it as the responsible, right thing to do," said David Seckman, the Natural Products Association's executive director and CEO. "This law is further proof that the dietary supplement industry is well-regulated and puts consumers first."
The Natural Products Association (www.NaturalProductsAssoc.org) is the nation's largest and oldest non-profit organization dedicated to the natural products industry. The association represents nearly 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health and beauty aids.
Last Updated ( Wednesday, 27 December 2006 )
Important Note: The information contained in this email message is not meant to replace the advice or opinion of your own personal physician. In no way, does the correspondence above represent a diagnosis or treatment of any illness or disease. Växa International always recommends that you seek the advice of your personal physician before starting any nutritional program.
Attend and FDA Recognition Status