Prime Sports Nutrition

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Passage 2

Despite statements on your product labeling marketing some of your products as a “RESEARCH COMPOUND” and “NOT FOR HUMAN CONSUMPTION,” evidence obtained from your product labeling, including your website, establishes that your products are intended to be drugs for human use.

Passage 3

“Looking To Build Lean Mass And Improving Strength While Maximizing Your Fat Loss Potential. LGD-4033 Has You Covered. LGD Is A Selective Androgen Receptor Modulator (SARM) That Usually Goes By The Name Ligandrol. It’s Known For Its Muscle Mass And Strength Increasing Properties That Actually Don’t Come With The Anabolic Side Effects. This Is What Makes It So Popular With Bodybuilders And Athletes. Ligandrol Acts Similar To An Anabolic Based Substance. It Has The Ability To Rapidly Increase Muscle Mass While Reducing Overall Body Fat. Increased Muscle Mass And An Increase In Strength Are Both Results Of The Selective Activation Of Androgen Receptors In The Muscles.”

Passage 4

“KEY BENEFITS o Improves Muscle Mass o Improve Stamina o Burns Body Fat o Boosts Testosterone”

Passage 5

“Medical Studies Have Demonstrated (And As Confirmed By Online Reviews About Testolone) That RAD-140 Is Highly Effective To Treat Degenerative Conditions Like Alzheimer's Disease. It Is Equally Effective To Provide Relief To Subjects With Androgenic Deficiencies.”

Passage 6

“Benefits Of Testolone (RAD140) o Anabolic To Androgenic Ratio of 90:1 o Improves Libido And Sexual Performance o Best SARM For Muscle Growth And Size. o Reduces Fat And Increases Muscle Mass. o Ideal To Enhance Body Composition. o Rapid Muscle Recovery”

Passage 7

“The Use Of Testolone Is Associated By RAD-140 Users With Dramatic Relief From Muscle Wasting Or Loss Or Muscle Tissue, Weakness, And Fatigue That Makes The Entire Otherwise-Complicated Processes Of Healing And Recovery Easy And Quick.”

Passage 8

“RAD-140 Users Can Expect Dramatic Fat Loss And Gain 5-15 Lbs Lean Muscle Mass Gains In As Short As Four To Six Weeks.”

Passage 9

“Benefits Of Ibutamoren (MK-677) o Increases Muscle Mass and Strength o Improves Tissue Regeneration o Increases Growth Hormone Levels o Clinically Proven GH Elevator o Enhanced Vitality And Faster Recovery o Reduces Body Fat o Increases Sleep Quality And Rapid Eye Movement (REM) Sleep o Increases Insulin-Like Growth Factor 1 (IGF-1) o Improves Basal Metabolic Rate”

Passage 10

“Looking To Boost Strength While Obliterating Fat? Let Us Introduce You To S23! One Of The Most Potent SARMs On The Market, Some Say That S-23 Is The Closest Thing To Conventional Steroids That You Can Get. An Excellent Cutting Compound, It Boosts Fat Loss Whilst Offering Impressive Lean, Dry Gains. This Compound Is Renowned For Developing A Dense, Hard Aesthetic With No Water Retention. If You’re Looking For Grainy-Looking Muscles, Then You Should Definitely Consider S-23.”

Passage 11

“KEY BENEFITS o Muscle Mass Increase o Fat Loss o Increased Endurance o Recover Times Are Shorter.”