Public Health Service Food and Drug Administration
Detroit District 300 River Place Suite 5900 Detroit, Ml 48207 Telephone: 313-393-8100 FAX: 313-393-8139
October 28, 2015
Mr. Manish Patel
Orgen Nutraceuticals, Inc.
6380 Commerce Drive
Westland, MI 48185
Dear Mr. Patel:
The U.S. Food and Drug Administration (FDA) inspected your firm located at 6380 Commerce Drive Westland, MI 48185 on July 8, 2015 through July 16, 2015. In August 2015 the FDA reviewed your website at the Internet address, www.orgennutra.com, and determined that you take orders for your dietary supplements products “Orgen Muk-O-Lite,” “Orgen Lipichol,” “Orgen Diabcont,” “Orgen Muc-O-Lite,” “Progen,” “Orgen Flax Seed Oil,” “Vedagara,” and “Orgen Melatonin,” which appear to be promoted for uses that cause the products to be drugs within the meaning of section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are intended for use in the cure, mitigation, treatment, or prevention of disease. Introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs
Examples of some of the claims on your website, www.orgennutra.com, that provide evidence that your products are intended for use as drugs include:
“How To Lower Blood Pressure And Cholesterol Naturally”
“To Maintain a Healthy Cholesterol Levels [sic] as well as healthy blood pressure numbers.”
“[P]hyllanthus niruri protects the pancreas from further damage through its anti-oxidant effect and effec tive [sic] glycaemic control.”
“[M]ost importantly helps regulate the blood sugar level.”
“It helps mobilize and remove the mucus from the bronchial tubes, especially during the flu season.”
“Folic acid along with other vitamins (Biotin and Cyanocobalamine) and amino acid (L-arginine) helps to prevent hair thinning and hair loss and promotes healthy hair.”
Orgen Flax Seed Oil
“It may help maintain a normal level of LDL-cholesterol.”
“[E]RECTILE DYSFUNCTION PILLS”
“Melatonin has been used for treatment of trouble sleeping (insomnia) due to sleep cycle disorders…”
Furthermore, the claims quoted above are supplemented by the language in the footer on your website. Examples of some of the claims in this footnote include the following: “[N]atural supplements for joint pain, joint pain… vitamins for joint pain… natural remedies for joint pain… flu symptoms… naturally reduce cholesterol…natural ways to lower blood pressure … lower cholesterol naturally…cholesterol lowering drugs… erectile dysfunction … natural remedies for ed… natural anti depressants, anti depression drugs… drugs for depression…”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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.
Your products “Orgen Lipichol,” “Orgen Diabcont,” “Orgen Flax Seed Oil,” “Vedagara,” and “Orgen Melatonin” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Your letter dated August 3, 2015 responded to the FDA-483 Inspectional Observations issued at the conclusion of the inspection. In your letter, you provided a Standard Operating Procedure for “Quality Control Authority and Responsibilities” and stated that you will not be conducting any label removing or label application operations for dietary supplements at your facility, or distributing dietary supplements with your name and address on the label. However, your website, www.orgennutra.com, continues to take orders for your products and to promote them for uses that cause these products to be drugs.
This letter is not an all-inclusive list of violations that exist in connection with your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for all of the products marketed by your firm to ensure that the claims you make do not cause them to violate the Act. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to promptly correct the violations may result in legal action without further notice, such as seizure or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations. Include any documentation that would assist us in evaluating your corrections. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to: Cicely Vaughn, Compliance Officer, U.S. Food and Drug Administration, Detroit District Office 300 River Place, Suite 5900, Detroit, MI 48207-4291. If you have any questions, you may contact Cicely Vaughn at (313) 393-8297 or via email at Cicely.Vaughn@fda.hhs.gov.