Response from Bass & Boney Pharmaceuticals, Inc. to the FDA, in reference to our products.
Rosacea-ltd has never had a "clinical medical problem" since starting in 1995 and selling Rosacea-Ltd internationally since June 1997. And likewise, the FDA nor a consumer has ever found or reported a "clinical medical problem" as a result of using our products on the skin while suffering from rosacea, sebhorrheic dermatitis, eczema, psoriasis or acne.
The FDA reports only "word choice useage problems" or "quibbling over words" or semantics called FDA law guidelines (which changes with each inspection and with each inspector as found in June 2001 after operating since June 1997 with the same words and repeated FDA inspections. Corrections were made within 2 days (and took 10 minutes by our web master) after being notified to do so for the "errors in labeling or branding" literature that we produced for our United States and International rosacea sufferers. In reading the FDA letter, it reflects the contrary of a horrible situation affecting all 'products' which is a very gross misprepretation and misuse of their "words" which is "libel" and criminal under 50 state statues if the same case were a personal or business situation. The FDA should not have implicated 'all' of our products when there was a 'mislabeling' or 'wording' product with just one product of Acne-Ltd III that words defining Acne-ltd III has having "antibiotic properties which it does but we can not say it own our web site. Their mistake is very much like labeling 'an entire family' when one family member has a physical or mental problem.
Sometimes in our personal lives and business, our biggest problems are 'Egos And Empires'. We all know that if we hold our breath for 30 seconds or for one minute that our face turns red even if we do not have rosacea. We know well that lack of water (two atoms of hydrogen and one atom of oxygen) which is called dehydration is large factor and cause of rosacea. The FDA has not approved neither water nor oxygen for the use of rosacea and likewise would be "mislabeled and misbranded" if anyone sold oxygen or water for use in the treatment of rosacea. Our "Case Point" is that an "Empire" could "label and misbrand" during their inspection of a product to make the product sounds like quackery, even if it works wonderfully well, was inexpensive, readily available, and without "clinical medical side effects" for rosacea, sebhorrheic dermatitis, eczema, psoriasis or acne.
Attorneys Gary L. Yingling and Emalee G. Murphy of the law firm of Kirkpatrick & Lockhart of 1800 Massachusetts Avenue, NW, Suite 200, Washington, DC 20036-1221 have been of great assistance in understanding how to better work with the FDA. Mr. Yingling previously served as President of the Food and Drug Law Institute for nine years. He worked for ten years as a trial lawyer and Associate Chief Counsel. During those 10 years, he was also Director of the Over-The-Counter Drug Review. In 1974, he received the FDA's Award of Merit, the Agency's highest award, for his legal work on the OTC Review. Mr. Yingling is a recipient of the FDLI's 1998 Distinguished Service and Leadership Award, presented each year to honor an outstanding practitioner in food and drug law. Since 1997, Bass & Boney, Inc. has been honored to have Mr. Yingling, an FDA approved 'man of merit', assisting and guiding us with all of our representations on the internet, labeling, and correspondence with the FDA and customers.
Our most recent inspection on April 3, 2003 again (as you will see below) was without incident of any type. The FDA inspector made one recommendation that was greatly appreciated as it added dimension and depth to our existing wording or claims in the first paragraph of each web site. Click here to read the April 3, 2003 inspection Form 482.
The purpose of this documentation is to show a chronological order of the various inspections prior to the April, 2003 inspection which will easily clear any misunderstanding or misconceptions about our products (Acne-Ltd III, Cellulite-Ltd III, Dermatitis-Ltd III and Rosacea-Ltd III) with the FDA:
- 03.31.1999 - the FDA inspection found Bass & Boney, Inc., and our products to be "in compliance" with the FDA guidelines.
- Based on this finding, the Atlanta District may recommend approval of pending pre-market applications, drug applications and supplements, or export certificates for your product(s).
- FDA PUBLIC MEETING: Should health claims be allowed on dietary supplements on a basis other than significant scientific agreement? If so, what should that basis be and what are appropriate criteria for making decisions about such claims? In Pearson v. Shalala, the United States Court of Appeals held unconstitutional under the First Amendment four FDA rules that suppressed four separate health claims.  The Courts decision invalidated the agencys rules. As a matter of law the rules are of "no further legal force or effect", yet the FDA "continues to try to enforce them" which is contrary to the court's decision and is unlawful as it is 'contempt of court'. That's pretty bad for an enforcement agency to be disprefectful to the Courts of the United States.
A little back history is to note that the prior FDA inspection of March 31, 1999 found Bass & Boney, Inc., and our products to be in compliance with the FDA guidelines as noted in the second paragraph of the below letter and went further in the third paragraph by stating, Based on this finding, the Atlanta District may recommend approval of pending pre-market applications, drug applications and supplements, or export certificates for your product(s). Click here to read the July 29, 1999 FDA letter.
We would like to take the opportunity to clear up by showing the case of the court of the United States of America was decided in favor of the people of the United States and "against the FDA with the FDA being informed by the court to become compliant" by implementing this document, taken from the website of www.emord.com.
The FDA in co-operation with the FTC as well as other government agencies are working very diligently against immense odds to assure the American consumer truth in advertising along with trying to ensure that the products they purchase will be safe for use and that they will do what they claim to do.
We at Bass & Boney, Inc., wholly support their efforts, and with each of our inspections have learned new and better ways to deliver the best to our consumers.
The above tells only a very small part of the entire historical story. Just as most automobile drivers have had a ticket or two if they have been driving for years, almost all medical products companies have likewise received tickets or warning letters from the FDA. We have a list of other FDA and/or FTC warning letters issued to the makers of other skin products.
Thanks for taking the time to read and think through the issues that we face in the United States and with various agencies of government that sometimes go too far in interpretation and implementation of the law even in defiance of the U.S. Courts.
Ralph L. Bass