Department of Health and Human Services
Public Health Service
7520 Standish Pl
October 6, 2001
Klee Irwin, President & CEO
Omni Nutraceuticals, Inc.
5310 Beethoven St
Los Angeles, CA 90066
Ref. No. 02-HFD-312-02
Dear Mr Irwin:
This letter concerns INHOLTRA® JOINT PAIN™ CAPLETS and INHOLTRA® JOINT PAIN PLUS™ CAPLETS (Inholtra Products), which are marketed by your firm as combination drug-dietary supplement products. According to the respective package labeling, each tablet of INHOLTRA® JOINT PAIN™ CAPLETS contains, among other ingredients, 325 mg of acetaminophen and 375 mg of glucosamine sulfate, and INHOLTRA® JOINT PAIN PLUS™ CAPLETS contains, among other ingredients, 325 mg of acetaminophen, 187.5 mg of glucosamine sulfate, and 150 mg of chondroitin sulfate" Both products are labeled for use as "A NEW TWO-IN-ONE SOLUTION" to " [t]emporarily relieve minor aches and pains due to: headache, backache, muscular aches, and the minor pain of arthritis…" and "for Long Term Joint Health." The labeling for INHOLTRA® JOINT PAIN™ CAPLETS specifies that it is "the only product to combine the fast pain relief of Acetaminophen with the healthy long-term joint support of the Inholtra Glucosamine," while the labeling for INHOLTRA® JOINT PAIN PLUS™ CAPLETS specifies that it is "the only product to combine the fast pain relief of Acetaminophen with the healthy long-term joint support of the Inholtra Glucosamine and Chondroitin complex." (Emphasis added.)
In addition, the respective package labeling contains a "DRUG FACTS' panel for the acetaminophen and a "Supplement Facts" panel for glucosamine sulfate for INHOLTRA® JOINT PAIN™ CAPLETS and for glucosamine sulfate and chondroitin sulfate for INHOLTRA® JOINT PAIN™ PLUS" CAPLETS. The labeling for both products also contains a disclaimer that states that the glucosamine sulfate in the former and the glucosamine sulfate and chondroitin sulfate in the latter is/are "…lot intended to diagnose, treat, cure, or prevent any disease…," and that the claims made for these ingredients "…have not been evaluated by the Food and Drug Administration."
As formulated and labeled, the Inholtra products described above are "drugs" under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are intended to cure or mitigate a disease (e.g., "relieves minor aches and pain due to … Arthritis" and "combine the fast pain relief of acetaminophen with the healthy long-term joint support of Inholtra Glucosamine (or) the Inholtra Glucosamine and Chondroitin complex."]. These products are also "drugs" under section 201(g)(1)(C) of the Act because they are intended to affect the structure or function of the body (e.g., "relieves minor aches and pains due to…muscular aches") . Notwithstanding your attempt to market these Inholtra products as combination drug-dietary supplements, the presence of the acetaminophen, with its intended use to relieve arthritis pain, renders the entire product a drug. This is true even though the acetaminophen in these Inholtra products is combined with other ingredients like glucosamine and chondroitin that separately could be marketed as dietary supplements. When, as here, a drug and dietary ingredients are combined into a single product, there is no provision in the Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA), that exempts any part of that product from the scope of section 201(g).
Under section 201(g)(1)(D) of the Act, the glucosamine sulfate or glucosamine sulfate and chondroitin sulfate used in combination with the acetaminophen are also drugs since they are components of the finished drug product. See Title 21 of the Code of Federal Regulations, Part 210.3(b)(3) [21 CFR 210.3(b)(3)]. Based on the labeling claims made for them (e.g., "Long Term Joint Health"); the glucosamine sulfate and chondroitin sulfate are also drug ingredients under 21 CFR 201.66(b)(2).
Moreover, based on their formulations and labeling, these Inholtra products are "new drugs" under section 201(p) of the Act and 21 CFR 310.3(h) because these products are not generally recognized as safe and effective for their respective labeled uses. Neither of these products is subject to the Food and Drug Administration's (FDA's) Over-The-Counter (OTC) Drug Review because no other product formulated with these active ingredients and labeled for these intended uses has ever been commercially marketed, and the agency has never proposed that such a product be included in this Review. Thus, these Inholtra products violate section 505(a) of the Act because they are new drugs and neither is the subject of an approved New Drug Application (NDA).
The Inholtra products described in this letter are also misbranded under section 502(f)(1) of the Act because they lack adequate directions for use as defined in 21 CFR 201.5, 310.201(a)(1)(vii), and 21 CFR 369.21. Under these regulations, the labeling for an OTC drug product that contains acetaminophen is rewired to specify the duration of administration and contain specific acetaminophen warnings. The respective labeling for these Inholtra products includes the statement, "[s]top use and ask a doctor if…pain gets worse or lasts more than 10 days…," but does not warn consumers about the need to consult a physician before giving acetaminophen drug products to children under three years of age. In addition, this "stop use" statement is much less prominent than other, conflicting statements on the respective bottle labels, cartons, and carton inserts that promote the "long term" use of these products for maintaining joint health. For example, the respective principal display panels of the package labeling and front panels of the bottle labels contain the phrase "[l]ong [t]erm." The respective carton end-flaps also state that the Inholtra product inside is "the only product to combine the fast pain relief of Acetaminophen with the healthy long-term joint support of [Inholtra Glucosamine (or) the Inholtra Glucosamine and Chondroitin complex]." In addition, inserts include the statement, "[w]e've combined these powerful pain fighters with clinically proven ingredients like Glucosamine and Chondroitin for long term joint health.…"
These Inholtra products are likewise misbranded under section 502(f)(2) of the Act because their respective labeling lacks adequate warnings. These Inholtra products are marketed for long-term joint health, but their respective warning state only that they should not be taken "if … pain gets worse more than 10 days." (Emphasis added). The labeling for these products does not bear a warning limiting use for long-term joint health. In fact, use of the phrase "[l]ong [t]erm" implies the products should be taken consistently over a long period of time. This contradiction raises serious safety concerns because these products contain acetaminophen, which, if used incorrectly, have the potential to cause hepatotoxicity. In addition, protracted pain may be a symptom of a more serious condition. Under 21 CFR 310.201(a)(1)(vii) and 21 CFR 369.21, over-the-counter use of acetaminophen for the temporary relief of pain is limited to 10 days unless otherwise directed by a doctor. This is true regardless of the other intended uses for which the acetaminophen product is sold.
Finally, the Inholtra products described above are misbranded under section 502(e)(1)(A)(ii) of the Act because their respective labeling fails to identify glucosamine sulfate for INHOLTRA® JOINT PAIN™ CAPLETS and glucosamine sulfate and chondroitin sulfate for INHOLTTRA® JOINT PAIN PLUS™ CAPLETS as active drug ingredients. See 21 CFR 201.10. The violations described in this letter are not meant to be all-inclusive. It is your responsibility to ensure, that all drug products manufactured and distributed by your firm comply with the Act. Federal agencies are advised of the issuance of all Warning Letters pertaining to drugs and devices so that they may take this information into account when considering the award of contracts. We request that you take action immediately to correct these violations. Failure to do so may result in regulatory action without further notice and may include seizure and/or injunction.
Please respond to this office in writing within fifteen (15) working days of receipt of this letter. Your response should describe the specific actions you will take, or have taken, to correct the violations described above. It should also include an explanation of each step being taken to prevent recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which corrections will be completed. Your reply should be directed to Mr Kevin M. Budich, Compliance Officer, as follows:
Food and Drug Administration
OTC Compliance Team, HFD-312
7520 Standish Pl #168
Rockville, MD 20855
If you have any questions about the content of this letter, you may contact Mr Budich at 301-827-7354.
David J. Horowitz, Esq.
Acting Director, Office of Compliance
This page was posted on August 20, 2006.