Inspections, Compliance, Enforcement, and Criminal Investigations
UAS Laboratories 13-May-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
May 13, 2005
RETURN RECEIPT REQUESTED
Refer to MIN O5-13
Sita K. Dash, Ph.D
9953 Valley View Road
Eden Prairie, Minnesota 55344
Dear Dr. Dash:
On January 25 and 27, 2005, FDA inspected your facility located at 9953 Valley View Road, Eden Prairie, Minnesota. During the inspection, our investigator collected copies of labeling for some of the products distributed by your firm. This inspection, the collection and review of your labeling, and a review of your Internet site, http://www.uaslabs.com, were conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and applicable-implementing regulations under Title 21 of the Code of Federal Regulations (21 CFR).
As a result of our inspection and review, we have identified serious violations of the the Act in the labeling of many products distributed by your firm. You can find the Act and implementing regulations through links on FDA's Internet home page at http://www.fda.gov.
Under section 201(g) (1) (B) of the Act, articles intended for use in the diagnosis, cure, mitigation, treatment; or prevention of disease are drugs [21 U.S.C.321(g)(1)(B)]. Information provided on your Internet site establishes that your "Probiotic" products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
The following products are identified in your product labeling, which includes your Internet site, as "Probiotics;"
ProBioPlus DDS® (capsules)
DDS®-Plus (non-dairy powder)
DDS® Junior (non-dairy powder)
DDS® Acidophilus (non-dairy powder)
DDS® 100 Acidophilus (tablets)
DDS® 100 Acidophilus (capsules)
DDS® Multi-Flora ABF (capsules)
Specific claims establishing that these probiotic products are intended to cure, mitigate, treat, or prevent disease (disease claims) include the following:
Under "About Us" drop down menu:
"Helicobacter pylori, the causative bacteria for ulcers, ca [sic] be inhibited with the consistent use of probiotics-Acidophilus and Bifidus."
"The major benefits that probiotic product [sic] offer: . . .Protect against E. coli infection.. . . Reduces vaginal infection and yeast infections. . .. Promote anticarcinogenic activity. . . . Help prevent peptic ulcer caused by H . pylori. . .. Reduces cholesterol. . . . [R]ecommended following antibiotic therapy or under conditions of yeast infection, ulcer, cholesterol . . . ."
Under "Products" drop down menu:
"DDS@-Junior: Indications and Usages: As an aid . . . following antibiotic therapy."
"[B]ifidus bacteria may play a role in fighting colon cancer and reducing blood cholesterol . . . . [L]eads to improving the odds against colon cancer."
Under "Link To. . . Media Coverage"
"Probiotics and Ulcers"
" Probiotics & Vaginal Yeast Infections"
"[U]se of probiotics can help prevent vaginal infections."
"The major benefits that probiotic products offer include the following:
...Protect against E. coli, salmonella and other bacterial infections....Reduced risk of vaginal infection and yeast infection. . . . Promoting anticarcinogenic activity. . ...Helping to prevent peptic ulcer caused by H. pylori. . . . Reducing cholesterol."
" [U]sed in the prevention of rotaviral diarrhea in children and adults."
" DDS-1 L. Acidophilus: A Natural Antibiotic . . . the most proven track records of probiotics. . . . [H]as antibacterial activity against many strains of harmful bacteria. It has shown inhibitory activity against the following bacteria: . . . Streptococcus faecalis, . . . Sarcina lutea, Serratia marcescens,. . . Escherichia coli, Salmonella typhosa,. . . Shigella dysenteriae. .. . Pseudomonas aeruginosa, Klebsiella pneumoniae, Vibrio comma"
o"The use of probiotics in the field of H. pylori infection has become an important adjunct treatment to lessen side effects of your doctor's prescribed treatment. .. ."
o"[P]robiotics not only inhibit H. pylori but also help to prevent ulcers caused by use of painkiller medications."
In addition, information provided on your Internet site establishes that the product Joint Formula Glucosamine/Chondroitin with Boswellia 8s MSM is also a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. This information includes a claim that this product is intended as a treatment for "joint pain sufferers." This claim is also found in your product catalog, which is further evidence that this product is intended for use in the cure, mitigation, treatment, or prevention of disease. In addition, the promotional pamphlet entitled "UAS Joint Formula" includes the following claims, which also serve as evidence of intended use for this product:
"A natural approach to arthritis pain"
"[B]oswellia for potential pain relief."
"Recent studies show that glucosamine may even halt the progression of arthritis for many sufferers."
"[G]lucosamine slowed disease progression . .. ."
"[I]ndividuals with arthritis who took glucosamine sulfate daily experienced a similar reduction in symptoms as those taking ibuprofen."
"[G]lucosamine may help relieve pain, stiffness, and swelling."
"Rheumatoid arthritis sufferers report improvements with glucosamine supplements . . . ."
"For arthritis, boost glucosamine's effectiveness by taking it along with methyl sulfonyl methane (MSM) .. . . MSM has been shown in many studies to ease pain and inflammation for many rheumatoid and osteoarthritis sufferers."
"Chondroitin . . . may be as effective at relieving osteoarthritis pain as aspirin and other NSAIDs (nonsteroidal anti-inflammatory drugs) . . . ."
In summary, the claims identified above cause your ProBioPlus DDS® (capsules), DDS®-Plus (non-dairy powder), DDS®-Plus (capsules), DDS® Junior (non-dairypowder), DDSO-Acidophilus (non-dairy powder), DDS® 100 Acidophilus (tablets), DDS® 100 Acidophilus (capsules), DDS® Multi-Flora ABF (capsules), and Joint Formula products to be drugs, as defined in section 201(g) (1) (B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because these products are not generally recognized as safe and effective for the above referenced conditions, they are also new drugs as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. Under section 505(a) of the Act [21 U.S.C. 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
If you wish to market your products as dietary supplements and not drugs, you must revise the current labeling and products to comply with the Act and FDA's regulations. In addition, even if your Joint Formula product did not contain disease claims in its labeling which cause it to be a drug, this product would still be misbranded as a dietary supplement.
As a dietary supplement, your Joint Formula product is misbranded under section 403(q)(5)(F) of the Act (21 U.S.C. 343(q)(5)(F)] because the format of the Supplement Facts panel for this product does not comply with 21 CFR 101.36 .Specifically, your label lists dietary ingredients with established Reference Daily Intake (RDIs ) (i.e., Vitamin C and Manganese) and dietary ingredients for which FDA has not set a Daily Reference Value (DRV) or RDI (i.e ., glucosamine sulfate, chondroitin sulfate, boswellia serrata, etc.) as defined under 21 CFR 101.36(b)(2) and (b)(3), respectively. However, the product label does not segregate these different types of dietary ingredients (i.e., dietary ingredients as defined in 21 CPR 101.36(b)(2) and (b)(3)) into separate sections of the Supplement Facts panel as required by 21 CFR 101.36(b)(3)(i). Furthermore, heavy bars are required immediately after the listing of the last dietary ingredient required to be declared pursuant to 21 CFR 101.36(b)(2) and (b)(3), respectively (21 CFR 101.36(e)(6)(ii) and (iii)]
This letter is not intended to be an all-inclusive list of deficiencies for your products or their labeling. It is your responsibility to ensure that all products distributed by your firm comply with the Act and its implementing regulations, We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides for the seizure of illegal products and/or an injunction against the manufacturer and/or distributor of illegal products
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.
Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.
W. Charles Becoat