14 DAY TRIAL // They are presented as "plant products" or "herbal products" that are a healthy alternative to synthetic drugs. But the U.S. Food and Drug Administration has just seized over 14,000 units of Shangai- and Naturale-brand diet supplements.
"The supplements - including Shangai Regular, Shangai Ultra, Super Shangai, Naturale Super Plus and Lady Shangai - were valued at more than $100,000," said a FDA spokesman.
These "natural supplements" had all been labeled as healthy alternatives for treating erectile dysfunctions and for boosting sexual life, but FDA found that the products comprised undeclared active synthetic ingredients that could inflict severe side effects. That meant the products were drugs and their sale in US is illegal without FDA approval.
The products were made in China, packaged and distributed by Shangai Distributors Inc. of Coamo, Puerto Rico. An advertisement released by the FDA warns consumers to discontinue the use of these products and to pay a visit to their healthcare providers in case of experiencing any adverse effects.
A 2007 investigation revealed that products like Stamina-RX and Vigor-25, advertising an array of Asian panacea plants, could hide in fact illegal versions of the same Viagra, Cialis or Levitra they were supposedly meant to replace. The problem with these chemicals is that they cannot be combined with nitrates (which lower blood pressure) and unaware patients may think they are using Asian roots.
The market of "natural sexual enhancers" exploded by $400 million in 2006 in the US alone; and this is a high health risk for the 5.5 million American men medicating with nitrates. Moreover, the doses in some of these products are over two times higher than prescribed erectile-dysfunction drugs. Many patients visit emergency rooms after consuming "natural" sex pills all around the US, even men in their '30s. Like in Viagra and related products, the main side effects are sight and hearing impairments or severe headaches, continuous erection and spontaneous nose bleeding. One man was affected by strokes 20 minutes after ingesting an "extremely safe" Spontane-ES.
Consumers with heart or blood-pressure problems are usually warned not to take the sex pills within six hours after taking their heart medication, but specialists say at least 24 hours would be more adequate. Usually, the ingredients come from Asian countries (like China, Thailand and Malaysia), invading the market with cheap illegal stuff. A "herbal" Cialis costs $1-5; compare this with the pills made by Eli Lilly Co. and ICOS Corp., sold at the price of $13-20.
Illegal "natural supplements" hiding PDE5 inhibitors have been encountered in Thailand, Taiwan, Canada, Australia, New Zealand, Hong Kong, Malaysia, UK and the US, and 69 % of the Chinese sex pills contain the main ingredient of Viagra, sildenafil. A small chemical trick of the drug's molecule enables the maintaining of the desired qualities while bypassing customs checking as "diet supplements."
In 2006, the FDA banned eight "herbal" pills containing PDE5 inhibitors like in Viagra, Cialis or Levitra. Vigor-25 was presented as containing a mix of chemicals from Asian ginseng, lycium fruit and Chinese yam rhizome, while in fact it had just the active molecule from Viagra.