HIS Enterprise Inc dba Adam’s Secret USA, LLC
FDA issued a warning letter to HIS Enterprise Inc dba Adam's Secret USA, LLC for marketing multiple 'Adam's Secret' sexual enhancement products and 'Dr. Reade Slim Sense' as dietary supplements while laboratory analysis confirmed they contained undeclared pharmaceutical ingredients — tadalafil, sildenafil, and lorcaserin. These products were deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act and misbranded under section 502 for failing to declare active drug ingredients and lacking adequate directions for use. The undeclared PDE-5 inhibitors pose serious risks of dangerous drug interactions, particularly with nitrates, and lorcaserin (a withdrawn drug) carries cancer and psychiatric risks. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.
Flagged claims (10)
Clinically Proven Fat Binder 10 Day Plan (10 Capsules: Effective Weight Loss of 8-12 lbs/month Boosts Energy & Supports Metabolism
Many customers consume this enhancement pill on a weekly basis to revive their sexual confidence, as well as erections and stamina. Adam's Secret can also help men with erectile dysfunction, premature ejaculation, and weak prostate.
Forskolin works on muscles in the heart and in the walls of the blood vessels. It produces a more powerful heartbeat and widening of the blood vessels, which lowers blood pressure.
Tongkat Ali . . . It's often used to treat a variety of ailments, including fevers, erectile dysfunction, and bacterial infections.
Cnidium is most commonly used for increasing sexual performance and sex drive, erectile dysfunction (ED).
Stinging nettle is most commonly used for diabetes and osteoarthritis. It is also sometimes used for urinary tract infections (UTIs), kidney stones, enlarged prostate, hay fever, and other conditions.
Take 45~60 minutes before sexual activity to produce harder, bigger and longer erections. One capsule will be effective for up to 4 days and always under your control. Get hard when you want. This pill is all you need to enhance your blood flow and testosterone level whenever there's sexual activity.
Adams Secret is a holistic alternative to big pharma and is comparable to popular prescription drugs.
Clinically proven fat burner for healthy and safe weight loss.
Epimedium Sagitatum . . . It is sometimes referred to as a 'natural viagra' because it similarly increases blood flow to the penis, just like Viagra, without the potential side effects.
Required actions (2)
Please submit a written response to this letter within fifteen working days from the date of receipt, explaining 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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker