Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm487353.htm
Timestamp: 2019-04-22 10:25:18+00:00

Document:
The United States Food and Drug Administration (FDA) conducted an inspection of your own-label distribution facility, Lucy’s Weight Loss System (dba Waisted with Lucy), located at 813 Oram Street, Arlington, Texas from September 23, 2015 through October 7, 2015. At the conclusion of the inspection, a FDA 483 was issued to you. FDA also recently reviewed your websites at http://waistedwithlucy.com (redirects to http://pinkbikini.bigcartel.com/ and http://lucyscollection.bigcartel.com) and https://shortsonthebeach.com (redirects to http://shortsonthebeach.bigcartel.com/), as well as social media accounts (e.g. https://www.facebook.com/Waistedwithlucy/) used to promote your products. FDA has determined that the products you offer for sale, “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are unapproved new drugs under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs under sections 502 and 503(b)(1)(A) of the FD&C Act [21 U.S.C. §§ 352 and 353(b)(1)(A)].
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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
You market your Pink Bikini and Shorts on the Beach products as dietary supplements. 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 before it was authorized for investigation as a new drug. Therefore, “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition),” all of which contain sibutramine, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act.
FDA laboratory analysis confirmed that your “Pink Bikini (White Capsules)” contains undeclared diclofenac. Diclofenac is the active pharmaceutical ingredient in the FDA-approved drug Voltaren. According to section 201(ff)(3)(B)(i) of the FD&C Act, a dietary supplement cannot contain an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Voltaren as a new drug on July 28, 1988, and diclofenac was not marketed as a dietary supplement or as a food before this date. As such, “Pink Bikini (White Capsules)” cannot be a dietary supplement under section 201(ff) of the FD&C Act.
Your “Shorts on the Beach (Golden Edition)” also contains phenolphthalein. 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.
Your “Pink Bikini (White Capsules),” Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body and, thus, are drugs as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)].
In addition, your “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are also new drugs under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their 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 application approved by FDA under either section 505(b) or 505(j) of the FD&C Act [21 U.S.C. §§ 355(b) or 355(j)] is in effect for it. There are no FDA-approved applications on file for “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition).” The distribution or sale of these products without approved applications violates these provisions of the FD&C Act.
Furthermore, “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are also “prescription drugs” as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C § 353(b)(1)(A)], because, in light of their toxicity or other potentiality for harmful effect, or the method of use, or the collateral measures necessary for its use, each product is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition),” which contain undeclared sibutramine, are prescription drugs because 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. They are also prescription drugs because the FDA approval of Meridia was withdrawn because of serious safety risks. “Pink Bikini (White Capsules)” containing diclofenac, a non-steroidal anti-inflammatory (NSAID) drug which has been approved for marketing by FDA, is limited by an approved new drug application to use under the professional supervision on a practitioner licensed by law to administer such drug.
According to section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “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]. Prescription drugs can be used safely only at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved prescription 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 there are no FDA-approved applications for your firm’s “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition),” their labeling fail to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
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 . . ..” The failure to disclose the presence of diclofenac, sibutramine and/or phenolphthalein renders the labeling of your “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” misbranded under section 502(a) of the FD&C Act. 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 labels. The undeclared diclofenac contained in “Pink Bikini (White Capsules)” may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, NSAIDS (i.e. diclofenac) found in your “Pink Bikini (White Capsules)” could lead to serious gastrointestinal (GI) adverse events such as bleeding, ulceration, and fatal perforation of the stomach and intestines. Patients who are already taking medication that could cause bleeding may increase their risk of bleeding significantly by taking your “Pink Bikini (White Capsules).” Similarly, the label of “Shorts on the Beach (Golden Edition)” does not declare that it contains phenolphthalein. As previously stated, studies have indicated that phenolphthalein presents a cancer-causing risk.
“Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are also misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)], because the products’ labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of these products, particularly since someone who takes them would be unaware of the presence of the undeclared ingredients.
Likewise, “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are misbranded under section 502(j) of the FD&C Act, [21 U.S.C. § 352(j)], because they are 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 these misbranded products violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your 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, and to ensure that all products you manufacture or distribute are in compliance with the FD&C Act and all of its implementing regulations and all other requirements of federal law. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action of violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
FDA acknowledges that on September 23, 2015, you initiated a voluntary nationwide recall of all lots of “Pink Bikini,” “Shorts on the Beach (Blue Capsules)” 750 mg (30-count bottles), and “Shorts on the Beach (Golden Edition)” 800 mg (30-count bottles) distributed May 25 – June 30, 2015. The FDA has deemed this recall to be ineffective because you did not provide the Agency with a complete distribution list at the time of the recall. Product distribution lists are necessary so that audit checks may be conducted to ensure that customers receive the recall notification and either destroy or return the violative product. FDA also acknowledges that on December 9, 2015, you issued a voluntary nationwide recall of all lots of Pink Bikini (White Capsules), 750 mg (30-count bottles) to the consumer level, and on January 28, 2016, after meeting with FDA, you issued a voluntary nationwide recall to the consumer level of all lots of “Pink Bikini” and “Shorts on the Beach” in all colors, 750 mg (30-count bottles). In addition, we also acknowledge your FDA 483 response dated February 2, 2016, where you stated that you and those employed by your firm would cease to package and/or label any and all products that are considered a dietary supplement.
You should notify this office in writing within fifteen working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, please 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 all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections.
Your firm’s response to this letter should be sent to: Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact: John W. Diehl, Compliance Officer, at 214-253-5288.

References: § 321
 § 321
 § 321
 § 353
 § 352
 § 201
 § 352
 § 352
 § 321
 § 352
 § 352
 § 331