Umbrella

Selected passages from the FDA letter

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

Passage 1

FDA confirmed through laboratory analysis that a sample of your “Alpha Male Plus” contains the undeclared active pharmaceutical ingredient tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor.

Passage 2

Given that tadalafil was not marketed as a dietary supplement or as a food before Cialis was approved, “Alpha Male Plus,” which contains tadalafil, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.

Passage 3

because sublingual products are intended to enter the body directly through the skin or mucosal tissues, your “Alpha Male Plus” is excluded from the definition of a dietary supplement for this additional reason.

Passage 4

“Alpha Male Plus is a male enhancement supplement that improves sexual performance as a truly unique natural solution for erectile dysfunction. . . .”

Passage 5

Aside from helping with anxiety, and depression, this superb strain induces alertness and clarity so you will be able to think straight when using our premium Red Vein Bali Kratom. Thanks to its sedative effects, you can finally get a good night’s sleep and if you are experiencing chronic pain, try using Red Vein Bali Kratom as it is also an excellent analgesic and a great muscle agent as well. Some say this strain conjointly helps with narcotic addiction withdrawal and attention deficit disorder. . . .

Passage 6

Red Ketapang kratom is known for its painkiller-like qualities. It is said to be useful for managing chronic pain and a sedative effect that can aid sleep. . . . For those withdrawing from opiates, kratom has shown some benefit. Some varieties of kratom work like a stimulant and can be used for focus. At higher doses, psychological states may be affected. . . .

Passage 7

Tianeptine Sodium Solution is a potent mood brightener and nootropic, celebrated for its effects on wellbeing and cognition, providing immediate and also long term benefits. Within an hour of use, it provides mental stability and clarity, functioning as a medium duration productivity tool. Additionally, its beneficial effects compound over extended use, resulting in a long-term effect which reduces feelings of stress, sadness and anxiety.

Passage 8

BUY NACET FOR COVID-19 PREPARATION & SYMPTOM MITIGATION . . . Dietary supplementation with NACET improves the bioavailability of NAC in tissue cells (i.e. lung tissue at risk of COVID-19 induced oxidative damage). . . . Increased antioxidant potential and defense from COVID-19 induced oxidation

Passage 9

did you know it will mitigate the symptoms of COVID-19? . . . Given the rapid spread and global pandemic status of COVID-19, health profesionals [sic] are increasingly focusing on disease mitigation rather [sic] than disease containment. With over 2,000 confirmed cases in the US spread across 47 states, your odds of contracting COVID-19 are rapidly rising. The safe bet now is to prepare to deal with infeciton [sic] rather than naively hoping to avoid it. Crucially, a large body of the primary research demonstrates that dietary supplementation with the potent antioxidant N-acetylcysteine (NAC) can inhibit RNA virus replication and reduce the severity of associated diseases. NAC is a simple amino acid who [sic] antioxidant power adn [sic] bioavailability can be dramatically improved by simple enzymatic modication [sic] to N-acetylcysteine ethyl ester (NACET). This modification of NAC permits unprecedented protection of your blood cells from oxidative damage, thus enabling your body's immune system to effectively defend your body from ravages of COVID-19 . . . Visit our website learn more and buy NACET POWDER! . . . www.UmbrellaLabs.is . . . #COVID_19 #CoronaVirus #COVID” accompanied by a video displaying the text “PREPARE & MITIGATE WITH,” images of “NACET Nootropic Powder” and virus particles and the text “COVID-19”

Passage 10

With all the news about Corona Virus (COVID-19), the thoughts and worries are escalating quickly! It's time to take action and do what needs to be done to keep ourselves and our love ones protected! . . . Did you know . . . that dietary supplementation with NACET improves the bioavailability of NAC in tissue cells (i.e. lung tissue at risk of COVID-19 induced oxidative damage). . . . Boost your NAC levels and protect yourself from the worst symptoms of COVID-19! Visit our website and check out our BLOG to learn more! . . . www.UmbrellaLabs.is . . . #Corona #CoronaVirus #COVID . . .” accompanied by images of “NACET Powder Nootropic and virus particles with the text “COVID-19” and “PROTECT YOURSELF”

Passage 11

SARMs are unique compounds widely used as a form of testosterone therapy and replacement. . . . Unlike steroids, SARMs only activate the androgen receptors in your bone and muscle tissues, rather than generating a full-body response. This helps to protect the tissues in your prostate and cardiovascular system. As SARMs do not contain the same molecular ring structure as steroids, they are not classified as such. . . . As such, it’s specially positioned to address a range of health conditions, including breast cancer. The premise behind this mechanism is simple: Targeted tissues will respond to SARMs in a similar way as they would to testosterone or another anabolic steroid. However, other tissues that my produce undesirable side effects if targeted are not triggered. This allows you to receive many of the same benefits as conventional testosterone therapy, without incurring many of the associated risks.

Passage 12

Women who suffer from low testosterone might find that steroid therapies leave them feeling unfeminine, with a deeper voice than they’re [sic] normal. This is one of the unique benefits of SARMs. These supplements are tissue-specific, focusing on your bones along with your muscles. This means they only raise testosterone levels there, rather than amplifying them throughout your body. This is excellent news for women, who are more likely than men to develop osteoporosis as they age. . . . By undergoing SARMs therapy, women and men alike can take a targeted approach to strengthening their bones and muscles together.

Passage 13

Before you begin your quest, take the time to consider why you’re looking to buy SARMs in the first place. Which particular ailments are you looking to address? Will these SARMS be for your personal use or are you looking to help a loved one who has tried traditional therapies in the past to no avail? Once you know the answers to these questions, you can begin to look for the specific kinds of SARMs you need to address your particular pain points. In our online store, we offer a variety of SARM compounds in liquid and powder form . . . You can learn more about each product and discover more by browsing our online shop.” The words “online shop” are hyperlinked and direct consumers to the product page on your website https://umbrellalabs.is/online-store/SARMs-c33887656 where your SARMs products are available for purchase.

Passage 14

The goal of sublingual absorption is to get substances (i.e. SARMs) into systemic circulation and delivered to target organs (i.e. muscles and bones) without first passing through the liver. . . . Every substance this absorbed in the gastrointestinal tract passes through the liver before it gets distributed throughout the body. To bypass this “first-pass effect”, follow these steps:

Passage 15

Rad 140 works for me, my muscles became firm and larger at around the 4th -6th week