Department of Health and Human Services
Public Health Service
5100 Paint Branch Parkway
February 28, 2003WARNING LETTER
VIA OVERNIGHT DELIVERY
Eric Organ, President
D&E Pharmaceuticals, Inc.
206 Macopin Rd
Bloomingdale, NJ 07403
Dear Mr. Organ:
The Food and Drug Administration (FDA) has reviewed your web site at the address:http://www.thestimulantpeople.com. This review shows what we believe to be violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of your products Ephedra Super Caps, Bolt Natural, and On The Go. You can find the Act and the dietary supplement labeling regulations through links on FDA's Internet home page at: http://www.fda.gov.
Under the Act, dietary supplement labeling may include claims about the supplement's effect on the structure or a function of the human body. To be permissible under the Act, these "structure/function" claims must be truthful and may not be misleading.
The labeling of Ephedra Super Caps, Bolt Natural, and On The Go bears structure/function claims that include the following:
- Ephedra Super Caps: "preferred product among those looking for greater...strength levels."
- Bolt Natural: "proven to give you extended hours of endurance when you need it most," and "high-performance athletes.. . have discovered their true potential with Bolt Natural."
- On the Go: "whenever you require peak performance."
Based on the scientific data available to us, we do not believe that these claims are substantiated. If these claims do not have an adequate scientific basis, they are false or misleading and cause your products to be misbranded within the meaning of Sections 403(a)(1) and 403(r)(6)(B) of the Act. Section 301(a) of the Act prohibits the introduction or delivery for introduction into interstate commerce of any food, including a dietary supplement, that is misbranded. Section 301(k) of the Act prohibits the doing of any act with respect to a food, including a dietary supplement, if such act is-done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being misbranded. If you have data which you believe substantiates your claims, please share it with us within fifteen (15) working days of your receipt of this letter.
In addition, except for health claims authorized by FDA, claims that a dietary supplement is intended to prevent, diagnose, mitigate, treat, or cure a disease (disease claims), may cause the supplement to be an unapproved new drug. The Act prohibits the introduction of unapproved new drugs into interstate commerce. If you are making disease claims for Ephedra Super Caps, Bolt Natural, or On The Go, please be aware that these claims may violate the Act and subject you or the products to regulatory action without further notice.
This letter is not an all-inclusive review of your web site and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against the manufacturers and distributors of those products. You should take prompt action to correct any violations identified in this letter. Failure to do so may result in enforcement action without further notice.
Please advise this office, in writing and within fifteen working days of receipt of this letter, as to the specific steps that you have taken to correct any violations and to assure that similar violations do not occur. If corrective action cannot be completed with fifteen working days, state the reason for the delay and the time within which the corrections will be made.
Any reply should be sent to the attention of Compliance Officer Quyen Tien at the above address.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition
This page was posted on July 2, 2005.