Sunday, August 23, 2015

Iowa Dietary Supplement Firm Shuts Down Under Consent Decree

U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.  
The company and its owners marketed their products online at and through online marketplace websites, such as eBay, Amazon and They also sold their products through a retail location in Cedar Rapids, Iowa. 
“The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “But when a company refuses to comply, we will take aggressive enforcement action.”

FDA: CBD oil not a dietary supplement

A warning letter went to a seller of CBD Oil: 

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address[1] in November 2014 and has determined that you take orders for several products that you claim contain cannabidiol (CBD), including but not limited to “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops,” which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], because the products are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
Examples of claims observed on your website that establish the intended use of your products include, but may not be limited to: 
On the “CBD oil – Pure Vape E-Drops 50mG” product webpage,
• “A literature review from 2009 recapped CBD’s documented capabilities as an . . . antipsychotic . . . vasorelaxant (lower blood pressure), antispasmodic, anti-ischemic, anti-cancer agent . . . antibacterial agent, anti-diabetic . . .”
On the “Hemp oil – Dixie Botanicals Dew Drops” product webpage,
• “EXPLORING SEVEN HEALTH BENEFITS OF CANNABIDIOL (CBD) . . . antipsychotic, anti-depressant . . . analgesic for rheumatoid arthritis . . . stimulating new bone growth and strengthening bones affected by osteoporosis . . . vasorelaxant for glaucoma . . . atheroscloerosis [sic], anti-ischemic (prevents plaque buildup in arteries)”
On the “CBD Oil” webpage,
Under the heading, “Study: Cannabinoids Could Play A Role In Pancreatic Cancer Treatment”:
 “[A study] suggests that cannabinoids could help treat pancreatic adenocarcinoma – one of the most aggressive forms of cancer.”
 “[T]he administration of cannabinoids seemed to induce cancer cell apoptosis . . ..”
Under the heading, “CBD May Help Reduce Psychotic Symptoms of Schizophrenia”:
 “CBD has shown promise in preventing cancer from cigarette smoke, reducing heart damage from chemotherapy . . ..”
 “[Researchers] compared benefits of CBD and amisulpride, a potent antipsychotic, in 42 acute schizophrenia patients . . . . The researchers found that cannabidiol and amisulpride were both ‘safe and effective’ but they declared CBD superior . . . .”
It is clear from the claims above that your marketed products “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are drugs under section 201(g)(1)(B) of the Act because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the 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. 
Additionally, your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because the labeling for these products fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Your marketed 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 this drug safely for its intended purposes. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115].  Because the above-mentioned products lack FDA-approved applications, they are not exempt under 21 CFR §§ 201.100(c)(2) and 201.115.  For these reasons, these products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to: