‘Neophase’, a natural sex enhancer found to contain hidden drug ingredient, claimed by FDA on Feb 22, 2016, in a public notification of its official website.

After a recent analysis, the FDA is warning consumers not to purchase ‘Neophase Natural Sex Enhancer’, a natural sexual enhancement product promoted and marketed on various websites and at many retail stores.

A thorough lab analysis confirmed that the product contained hydroxyacetildenafil, a chemical ingredient structurally identical to sildenafil.

  • Sildenafil (found in ‘Neophase’ as hydroxyacetildenafil) is FDA approved active ingredient found in the prescription drug Viagra, which is generally used to treat erectile dysfunction (ED).
  • Hydroxyacetildenafil, on the other hand, could interact with certain ingredients found in prescription drugs, such as nitrates, and cause potentially dangerous hypotension. People with diabetes, hypertension, hypercholesterolemia or any heart condition are strictly advised to avoid Neophase Natural Sex Enhancer.

The ‘Neophase’ contains the same ingredients found in approved prescription drugs such as Viagra, Cialis, and Levitra, or their analogs. These should only be available by prescription and used under strict medical supervision. Products that are in violation of federal law include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

In 2014, Kamran Rezapour of Creston, North Carolina confessed to committing fraud and selling nearly $5 million worth of ‘all natural’ erectile dysfunction drugs. He was subsequently sentenced to 108 months in prison.

Dietary Supplements Containing Hidden Ingredients Considered Potentially Dangerous

Lawful dietary supplements contain vitamins, minerals and other dietary ingredients that serve as a healthy addition to a standard diet. The FDA regulates such products under the Dietary Supplement Health and Education Act, passed by Congress in 1994. Unlike prescription drugs, dietary supplements do not need an approval from the FDA before they are marketed, making the manufacturers and distributors solely responsible for selling a ‘safe’ product. Under FDA’s Current Good Manufacturing Practices, manufacturers need to implement proper quality assurance controls for their supplements, including controls to prevent contaminants and adulteration.

In the past few years, the FDA has warned consumers against the use of almost 300 suspiciously marketed dietary supplements, and has also received numerous complaints of adverse effects with regard to their use. In a letter in 2010, the FDA has expressed concern about the use of concealed ingredients and/or deceptive labeling of dietary supplements. These hidden ingredients include active ingredients in FDA-approved drugs or closely-related drugs, as well as other compounds such as unique synthetic steroids that cannot be characterized as dietary ingredients.

The Food and Drug Administration (FDA) has recently come to recognize a growing and worrying trend of over-the-counter products, in particular dietary supplements and sexual enhancement products, containing hidden and potentially harmful active ingredients. The latter include varied quantities of ingredients used in approved prescription drugs, controlled substances, and unstudied and untested pharmaceutically active ingredients. These covert substances can not only cause chronic health disturbances, but can also be potentially fatal.

Common Categories of Illegal Products and Reported Cases Other than Sex Enhancer Drugs:

According to their analysis, the FDA claims the following two products also contain the most illegal products other than sex enhancer products:

  1. Weight Loss Products

Most of these products contain the active ingredient sibutramine, which is found in the drug Merida and was recently recalled from the market due to its association with an increased risk of heart attack and stroke. Various products, including Slimming Beauty, Solo Slim and Slim-30 have been found to contain sibutramine or similar drugs.

The 2010 prosecution of Shengyang Zhou, a Chinese national is an example. Zhou was put behind bars in Texas for trafficking illegal versions of weight-loss pills and so-called dietary supplements and nutritional products that were found to contain sibutramine.

  1. Body-building Products

These products often contain anabolic steroids or steroid analogs that increase the risk of heart attacks and cause may also cause acute liver injury. Products such as Tren Xtreme, ArimaDex, and Clomed fall under this category of dangerous products, since they also contain aromatase inhibitors which prevent the conversion of anabolic steroids to estrogen.

A case with regard to this was seen in May, when the US Department of Justice (DOJ or Justice Department) sentenced Joseph De Melo from New Orleans to 15 months in prison for dispensing anabolic steroids and intentionally mislabeling a dietary supplement that contained drugs meant for erectile dysfunction.

What Must Be Done

“Consumers should avoid buying and consuming products marketed as supplements and claiming to have effects similar to prescription drugs. They should also be aware of products labeled only in a foreign language, or those marketed through mass e-mails”, suggests Michael Levy, Director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research.

It is quite clear from the FDA’s approach that manufacturers and distributors will be held accountable for the quality and lawfulness of their product. “The manufacturers selling tainted products are operating outside the law”, stated FDA Commissioner Margaret A. Hamburg, M.D. “Companies involved in the making or distribution of tainted products are liable to receive warning letters and/or face enforcement actions, such as ceasing their product, injunctions, and even criminal prosecution.”

Moreover, five major trade associations, namely the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association has decided to assist the FDA in their fight against fraudulent products.

Last, but not the least, healthcare professionals and patients must be encouraged to immediately and openly report any adverse effects with regard to such products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Programs.

Meanwhile, the FDA is asking for the input and collaboration of dietary supplement trade associations to educate both, health officials and the general public regarding the gravity of the matter and what strategies can be formulated to combat these events.