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WARNING LETTER

April 16, 2020

Re: 594850

Dear Mr. Villalobos:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 4102 Orange Ave, Ste 118 & 119, Long Beach, CA 90807 on September 24 and 30, 2019. Based on laboratory analysis of your product and a review of your product labeling, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.

Adulterated Dietary Supplements: Unsafe Food Additive

Your Skinny Pill product is adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains 1,3-dimethylamylamine (DMAA), an unsafe food additive under section 409(a) of the Act [21 U.S.C. § 348(a)]. If a substance added to food is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive.¹ Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(C)(i)].

The definition of “food additive” in section 201(s) of the Act [21 U.S.C § 321(s)] does not include dietary ingredients used in dietary supplements as defined in section 201(ff)(1) of the Act [21 U.S.C § 321(ff)(1)] or substances that are GRAS under the conditions of intended use. DMAA does not qualify as a dietary ingredient under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)] because it is not a vitamin, mineral, amino acid, herb or other botanical, dietary substance for use by man to supplement the diet by increasing the total dietary intake, or concentrate, metabolite, constituent, extract, or combination of any of the preceding dietary ingredient types. Neither is DMAA GRAS under its conditions of use in your dietary supplement product. Because DMAA does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your Skinny Pill product is adulterated under section 402(a)(2)(C)(i) of the Act because it contains an unsafe food additive. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)].

The FDA recognizes that your firm voluntarily destroyed your inventory of Skinny Pill on September 24, 2019, and the product is no longer listed for sale on your website, www.losefatgainlifemb.com. FDA has also issued a warning to consumers not to use Skinny Pill (see Skinny Pill Immediate Public Notification).

Unapproved New Drug and Misbranded Drugs

FDA reviewed your website at www.losefatgainlifemb.com in March 2020 and has determined that you take order there for the products Reishi Coffee, Sugar Control, Blood Pressure Support, Fat Burner, Hear Clear Ear Health Formula, Hemp Oil, Liquid Gold, Omega 3, and Ovary Care. FDA also reviewed your Facebook page at www.facebook.com/LoseFatMB/ and your Instagram page at www.instagram.com/losefatgainlifembofficial in March 2020, which sites link to your website at www.losefatgainlifemb.com. The claims on your website, Facebook page, and Instagram page establish that your Reishi Coffee, Sugar Control, Blood Pressure Support, Fat Burner, Hear Clear Ear Health Formula, Hemp Oil, Liquid Gold, Omega 3, and Ovary Care are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they 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 some of the claims from your website at www.losefatgainlifemb.com that provide evidence that your products are intended for use as drugs include:

Reishi Coffee

• “Helps: … Diabetes … Cancer cells … Urinary tract infections … Tumors”

Sugar Control

• “Helps with: High blood sugar … Excess glucose in blood … Diabetic foot”

Blood Pressure Support

• “Helps: … Control High Blood Pressure … Varicose veins … Hemorrhoids”

Fat Burner

• “… [B]alancing blood sugar levels.”
• “It also helps with … obesity, high blood pressure, chronic tiredness, and fatigue.”

Hear Clear Ear Health Formula

• “Ayuda evitar infecciones y dolor” (English translation: “It helps prevent infections and pain”
• “Ayuda a reducir el daño causado por la exposición al ruido” (English translation: “It helps reduce the damage caused by exposure to noise")

Hemp Oil

• “Helps Fight Cancer”
• “Lower Risk of Diabetes”
• “OCD”
• “PTSD”
• “Neurological disorders Such as schizophrenia”

Liquid Gold

• “Asthma”
• “Bronchitis”

Omega 3

• “Helps with: Protecting against alzheimer’s [sic] disease[,] Rheumatoid arthritis[,] Cardiovascular diseases[,] High cholesterol[,] Decreasing inflammation[,] Reducing risk of stroke and heart attack”

An example of a claim on your Facebook page that establish that your products are intended for use as drugs includes:

• On June 25, 2019, your company posted an image of your Hemp Oil product surrounded by the following language: “Benefits of Hemp Cannabidiol (CBD) …ANTIPSYCHOTIC Combats Psychosis Disorders[,] ANTI-OXIDANT Combats Neurodegenerative Disorders[,] ANXIOLYTIC/ANTIDEPRESSANT Combats Anxiety and Depression Disorders … ANTI-TUMOR/ANTI-CANCER Combats Tumor and Cancer Cells.” You caption this photo post with “Hemp Oil” and provide a link to your website where you offer this product for sale.

Examples of some of the claims on your Instagram page that establish that your products are intended for use as drugs include:

• On September 28, 2019: “Ovary Care… Helps … Prevent ovarian cancer, Cysts in the ovaries, Polycystic ovary syndrome …Swelling in lower abdomen, Has anti-pasmodic action [sic]”
• Your Instagram page also contains evidence of intended use in the form of the following personal testimonial recommending or describing the use of your Sugar Control for the cure, mitigation, treatment, or prevention of disease. On July 4, 2019: “Le doy gracias a Dios Porke [sic] me ciento [sic] bien con mis productos después de tanto tiempo con esta condición de la diabetes de tenerla a 580 y antes de tomar sugar control la tenia 480 y ahora la tengo 344” (English translation: “I thank God because I feel good with my products after being with diabetes for a long time having it was at 580 and before taking sugar control, I had 480 and now I have 344”)

Your Reishi Coffee, Sugar Control, Blood Pressure Support, Fat Burner, Hear Clear Ear Health Formula, Hemp Oil, Liquid Gold, Omega 3, and Ovary Care products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Reishi Coffee, Sugar Control, Blood Pressure Support, Fat Burner, Hemp Oil, Liquid Gold, Omega 3, and Ovary Care are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Reishi Coffee, Sugar Control, Blood Pressure Support, Fat Burner, Hemp Oil, Liquid Gold, Omega 3, and Ovary Care fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates 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 list 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, including 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 that 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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 written reply should be directed to Aaron Dotson, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Aaron Dotson at [email protected].

Sincerely,
/S/

William A. Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition

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1 Under section 201(s) of the Act [21 U.S.C. § 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement.