Green Planet’s Night Bullet Male Sexual Enhancer in Hot Water with FDA

Dietary supplement manufacturer Green Planet Inc. has received a warning letter from the U. S. Food and Drug Administration, addressing the fact that their male sexual enhancement pill, Night Bullet, contains the same active ingredients as Viagra and is being marketed as a medication without the federal agency’s approval.

The FDA is demanding the company either revise their label, or send in their products to undergo FDA approval. If Green Planet does not do either, the company will be in violation of the Federal Food, Drug, and Cosmetic Act, and possibly false advertising.

This warning letter was sent on Dec. 5, 2013 to Anil K. Malhi, the CEO of Green Planet. The letter said the agency collected data on the sexual enhancement supplement Night Bullet Male Sexual Enhancer from Jan. 17, 2013 to Feb. 6, 2013, from customer reviews, and physical samples.

The company specifically violated section 505(a) of the Federal Food, Drug, and Cosmetic Act, the FDA said. According to the letter, the Night Bullet capsule contains the ingredients: sulfohydroxyhomosildenafll and thiosildenafll, which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafll. This essentially means that each of these capsule pills have the same active ingredient as Viagra; commonly used to treat erectile dysfunction, but can be dangerous for off-label purposes. Additionally, these capsules also contain the most prominent ingredient in another erectile dysfunction treatment drug, Cialis, which would be aminotadalafll, a phosphodiesterase type-5 (PDE-5) inhibitor and analogue of tadalafll.

Because of these ingredients, the Night Bullet capsules are subject to FDA regulation because this drug is classified to prevent, treat, or cure a disease in a way that affects the structure and function of the body. Labeling statements of the Night Bullet, include, but is not limited to:

• Scientifically calculated to multiply your Sexual Drive and Stamina!
• Increase Male Size and Firmness
• Eliminate Premature Ejaculation

The FDA states that the Night Bullet Male Sexual Enhancer is a new drug, and is not generally recognized as safe and effective due to the lack of scientific data. Additionally, according to the ingredients of the Night Bullet, it should be classified as a prescription drug, due to the potential harm in the toxicity of their ingredients. The company had also failed to address the safety concern of possible drug interactions that their products might have had, with medications the patient may have already been taking.

The FDA states that the company must get back to them with in 15 days, to notify them that they have read and understood the letter. Green Planet must also produce a series of steps that they propose to correct these violations; an explanation must be included in each step, and the prevention of any future violations. If the company cannot respond in fifteen days, the company must contact the FDA ahead of time to explain why.

Failure to correct these violations will result in legal action without further notice against the company. Criminal charges may be brought against the company for false advertising and negligence, if they fail to submit the correction plan.

Sex Enhancement Drug False Advertising Complications

Men and women across America are trying various ways to maintain their sexual activity, and are resorting to alternative methods to do so. For this reason, sexual enhancement products have become a multi-billion dollar industry in the U.S., with products claiming to treat various libido complications. Despite the vast number of products there are, there is not much in the way is safety or consumer protection in the manufacturing of these products.

This has caused many of these diet supplementary companies to be sued for false advertising, negligence, concealing information, and misrepresenting a product.

Consumer Help for False Advertising

If you purchased a sex enhancement product and were disappointed by the results, you may be able to pursue compensation through a class action lawsuit. See if you qualify for free by filling out the short form at the Sex Enhancement, Sexual Arousal Products Class Action Lawsuit Investigation.