WARNING LETTER
Genesis Nutrition Ultra Slim dba Genesis Ultra Slim
MARCS-CMS 616040 —
August 06, 2021
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Maria Gonzalez
Recipient Title
Public Relations Contractor
Genesis Nutrition Ultra Slim dba Genesis Ultra Slim
10108 NW 77th Street
Doral
,
FL
33178
United States
info@genesisultraslim.com
mgonzalez@genesisultraslim.com
ketoultraslimplus@gmail.com
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II
United States
August 6, 2021
Case #:
616040
WARNING LETTER
Ms. Gonzalez:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your firm’s websites at www.fastweightlossgarcinia.com and www.ketoultraslimplus.com between June and July 2021 and has determined that your firm takes orders there for "Genesis Ultra Gold."  We have also reviewed your social media websites at www.facebook.com/genesisultraslim,
https://twitter.com/genesis_slim and
www.instagram.com/genesis_slim/; these social media websites direct consumers to your website
www.fastweightlossgarcinia.com
1
to purchase your products.  The claims on your websites and social media websites establish that your "Genesis Ultra Slim Gold" product is
intended for weight loss. Therefore, this product is an unapproved new drug sold 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 sold in violation of sections 502 and 301(a) of the FD&C Act, 21 U.S.C. 502 and 331(a). You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov
.
FDA confirmed through laboratory analysis that a sample of your
"Genesis Ultra Slim Gold"
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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.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.
FDA has issued a warning to consumers not to use
"Genesis Ultra Slim Gold"
(see Genesis Ultra Slim Gold Immediate Public Notification).
Unapproved New Drug
You market
"Genesis Ultra Slim Gold"
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, "Genesis Ultra Slim Gold," 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
"Genesis Ultra Slim Gold,"
is an article (other than food) 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).  Some examples of claims observed on your websites and social media websites that establish the intended use of your product as a drug include, but may not limited to, the following:
On your websites www.fastweightlossgarcinia.com and www.ketoultraslimplus.com
"Our natural blend of ingredients can benefit you by . . . [s]uppressing your appetite . . . [b]oosts your metabolism . . . [b]urn fat & calories . . . [i]ncrease energy levels . . ."
"Complete blend of 100% natural ingredients formulated to help you lose weight . . ."
On your website www.fastweightlossgarcinia.com
"Konjac root . . . slows the rate of digestion and the absorption of both fat and carbohydrates."
"[P]ineapple is anti-inflammatory . . ."
"Dry Green Apple Powder . . . has detoxifying properties because of the diuretic effect and it also helps relieve constipation."
On your Facebook Account www.facebook.com/genesisultraslim
January 22, 2020 posting - " Genesis UltraSlim Gold . . . Lose up to 20 pounds in just 4 weeks . . . Promotes weight loss"
On your Instaram Account www.instagram.com/genesis_slim/
May 7, 2021 posting - "Benefits . . . appetite suppression . . . reduce bloating . . . burns fat . . . reduce inches . . . potentiates weight loss . . . improves metabolism"
Your "Genesis Ultra Slim Gold" product is not generally recognized as safe and effective for its above referenced uses and, therefore it is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).  With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There is no FDA-approved application in effect for your product.
Misbranded Drug
Your “Genesis Ultra Slim Gold” product is 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. (See 21 CFR 201.5).  It is impossible to write “adequate directions for use” for "Genesis Ultra Slim Gold" 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 "Genesis Ultra Slim Gold" fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the FD&C Act.  Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your "Genesis Ultra Slim Gold" product is not exempt from the requirement that its labeling bears adequate directions for use 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 "Genesis Ultra Slim Gold" product is misbranded under section 502(a) of the FD&C Act because the labeling fails to reveal its sibutramine and phenolphthalein content, which are material facts with respect to consequences that may result from the use of this product.  As described above, sibutramine and phenolphthalein may pose health risks to consumers which are only compounded by the fact that neither ingredient is declared on the label.
"Genesis Ultra Slim Gold" is also misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product 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, "Genesis Ultra Slim Gold" 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 drug product is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
Your websites, www.fastweightlossgarcinia.com and www.ketoultraslimplus.com, also market the following products
: Genesis Ultra Slim Original Formula, Genesis Ultra Slim Fat Burner, Genesis Ultra Slim Colon Cleanse, Garcinia
Max, Genesis Ultra Slim Platinum, Keto Ultra Slim Plus, and Keto 15 Day Cleanse. While FDA has not tested these products marketed by your firm, you are responsible for ensuring that they do not contain undeclared ingredients.
A full 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.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written notification should refer to case #
616040
.
Please electronically submit your reply, on company letterhead, to
Dayna I. Martinez, Compliance Officer, at
ORAPHARM2_RESPONSES@fda.hhs.gov
.  In addition, please submit a signed copy of your response to
dayna.martinez@fda.hhs.gov
.
and
john.diehl@fda.hhs.gov
.
If you have questions regarding the contents of this letter, you may contact Dayna I. Martinez via phone at
787-729-8608
or email at dayna.martinez@fda.hhs.gov.
Sincerely,
/S/
John W. Diehl, M.S.
Program Division Director (Acting)
Office of Pharmaceutical Quality Operations, Division II
1
Your Twitter and Facebook accounts directs consumers to www.genesisultraslim.com, which redirects to www.fastweightlossgarcinia.com.
Content current as of:
09/07/2021
Regulated Product(s)
Drugs