- Issuing Office:
- New Jersey District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Jersey District Office|
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331- 4969
JUN 5, 2014
VIA UNITED PARCEL SERVICE
File No.: 14-NWJ-07
Joseph D' Arpa, Owner
Nutrishop of Brick, Inc.
323 Brick Blvd
Brick, NJ 08723
Dear Mr. D' Arpa:
This letter concerns a product that your firm distributes to consumers via your websites, www.bestpricezixiutang.com, www.beenaturalweightloss.com and in your Nutrishop retail store locations, 323 Brick Blvd, Brick, NJ 08723; 1818 Highway 35 N., Wall, NJ 07719; 980 Shrewsbury Ave, Ste. 9, Tinton Falls, NJ 07724; and 410 S. Main St., Ste. B, Lacey, NJ 08731. The U.S. Food and Drug Administration (FDA) obtained samples and product labeling of your product, "Zi Xiu Tang Bee Pollen," which you also refer to as "Classic/Original Zi Xiu Tang Bee Pollen" on your websites. As described below, this product is an unapproved new drug in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and a misbranded drug in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)].
FDA confirmed through laboratory analysis that a sample of your "Zi Xiu Tang Bee Pollen" contains undeclared sibutramine and phenolphthalein. Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
In the past year, you have received six import refusal letters from FDA stating that your products appear to be unapproved new drugs and that they contain undeclared sibutramine. In addition, statements on www.bestpricezixiutang.com suggest that you are aware that your "Zi Xiu Tang Bee Pollen" product may contain undeclared drug ingredients. However, despite this knowledge, you continue to offer this potentially dangerous product on your website with statements claiming it is "all-natural" and "safe."
You market "Zi Xiu Tang Bee Pollen" as a dietary supplement. However, under section 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(ii)], a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before it was authorized for investigation as a new drug.
The investigational new drug (IND) application for Meridia (sibutramine) was received by FDA on December 24, 1985, and sibutramine became authorized for investigation as a new drug under an IND on January 23, 1986. When Meridia was approved for marketing as a new drug in the United States, the existence of substantial completed clinical investigations of sibutramine became public. Based on the information available to FDA, sibutramine was not marketed as a dietary supplement or as a food until after it was authorized for investigation as a new drug. Therefore, "Zi Xiu Tang Bee Pollen," which contains sibutramine, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act.
Your "Zi Xiu Tang Bee Pollen" product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or function of the body and, thus, is a drug as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)]. Labeling statements documenting the intended uses include, but are not limited to, the following:
Under the tab, "What is Zi Xiu Tang? Zi Xiu Tang Ingredients," on www.beenaturalweightloss.com:
• "Rhubarb Root ... has been found to have anti-oxidant, anti-inflammatory, and anti allergy properties. Additionally, rhubarb is known to have anti-cancer fighting properties and might help in reducing the risk of cancer."
• "Chinese Wolfberry ... is very beneficial for boosting the immune system, antiaging, cancer prevention, liver protection and vision improvement."
• "Mulberry Leaf effectively controls insulin absorption, thus contributing to the control of Type 2 diabetes. It has also been reported, in Chinese medicinal handbooks that mulberry leaves contain substances which may fight against cancer cells."
Under "Lowers Blood Sugar" on www.beenaturalweightloss.com:
• "Zi Xiu Tang Bee pollen pills can: Lower blood sugar . . . Reduce blood pressure . . . Improve cholesterol levels"
On the homepage of your website, www.bestpricezixiutang.com:
• "Lose between 5 and 10 pounds in the first two weeks simply by taking two bee pollen capsule [sic]. . . . watch the pounds melt away . . . . "
On the webpage titled, "Zi Xiu Tang Information" www.bestpricezixiutang.com:
• "[l]mprovement of blood circulation to the brain . . . . "
In addition, your "Zi Xiu Tang Bee Pollen" is a new drug under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your marketing and distribution of "Zi Xiu Tang Bee Pollen" without an approved application violates these provisions of the FD&C Act.
"Zi Xiu Tang Bee Pollen" is also misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] in that the labeling for this drug 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]. It is impossible to write "adequate directions for use" for "Zi Xiu Tang Bee Pollen" for at least two reasons: 1) prior to withdrawal of Meridia's approval, FDA approval of sibutramine was limited to use under the professional supervision of a practitioner licensed by law to administer such drugs and 2) FDA approval of Meridia was withdrawn because of serious safety risks. As such, the labeling of "Zi Xiu Tang Bee Pollen" fails to bear adequate directions for its intended uses. "Zi Xiu Tang Bee Pollen" is not exempt from the requirement that its labeling bear adequate directions for use under 21 CFR §§ 201.100(c)(2) and 201.115 because no FDA-approved application is in effect for this product.
Additionally, under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act [21 U.S.C. § 321(n)], provides that, in determining whether an article's labeling or advertising "is misleading there shall be taken into account ... not only representations made or suggested ... but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations .... " Your product, "Zi Xiu Tang Bee Pollen" is misbranded under section 502(a) of the FD&C Act because, its labeling makes false and misleading statements regarding safety and fails to reveal material facts with respect to consequences that may result from the use of this product. As described above, sibutramine may pose serious health risks to consumers which are only compounded by the fact that sibutramine is not declared on the label.
"Zi Xiu Tang Bee Pollen" is also misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)], because the product's labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of this product, particularly since someone who takes it would be unaware of the presence of the undeclared ingredients.
Likewise, "Zi Xiu Tang Bee Pollen" is misbranded under section 502(j) of the FD&C Act, [21 U.S.C. § 352(j)], because it is dangerous to health when used in the dosage or manner recommended in the labeling. As previously noted, sibutramine poses an increased risk of heart attack and stroke.
The introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
FDA has previously alerted consumers about Zi Xiu Tang Bee Pollen Capsules sold by another distributor:
FDA has also issued a warning to consumers not to use Zi Xiu Tang Bee Pollen after receiving dozens of adverse event reports associated with its use: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm392163.htm
A list of all tainted products discovered by FDA can be found at: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist with your firm 's 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 products marketed by your firm comply with all requirements of federal law and FDA regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the FD&C Act.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice. The FD&C Act authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 332 and 334]. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
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 all of the violations described above. Include in your response documentation to show that corrections have been achieved. Furthermore, if another or additional firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
Your response should be sent to U.S. Food and Drug Administration, Mr. Joseph F. McGinnis, Director of Compliance, Food and Drug Administration, 10 Waterview Blvd, Parsippany, NJ 07054. If you have any questions with regard to this letter, please contact Mr. McGinnis at (973) 331-4902 or via email at email@example.com.
Director, New Jersey District