FDA Sends Warning Letter to Manufacturer of VitalErotic Shot

Some companies may use the blanket label of “alternative medicine” to try and skirt regulations designed to ensure that drugs are thoroughly tested for efficacy. In particular, there is a booming industry that produces drugs to promote sexual enhancement and performance. These products are marketed as remedies for lack of sex drive for both men and women. One such product, the VitalErotic Shot, produced by Precision Nutrition International Inc., has come under regulatory scrutiny for their marketing practices.

In July of 2013, the U.S. Food and Drug Administration (FDA) issued a warning letter to Precision Nutrition, indicating that the manufacturing and labeling practices were not up to the agency’s standards, the legal requirements for such a product. The letter was written in response to an inspection the agency conducted in 2012 of the manufacturing process for the VitalErotic Shot. Precision Nutrition markets the VitalErotic Shot as a “natural sexual enhancer” per the company’s website.

The warning letter indicated that there were several serious issues with the production of the VitalErotic Shot. According to the FDA’s warning letter, the manufacturers did not adequately test and measure the ingredients to determine purity and concentration. This could mean that the product in the bottle is not what the label indicates. The letter also stated that the manufacturers had no specific length of time they allowed their product to sit before being bottled, and could vary from days to months. Another infraction was the fact that the “best if used by” date was not supported by any kind of research data, the FDA investigation revealed.

While the FDA does review products like the VitalErotic Shot under the Dietary Supplement Health and Education Act (DSHEA), this is mainly concerned with labeling and manufacturing practices for dietary supplements, not their efficacy. Under the DSHEA, dietary supplements have much laxer standards than traditional medications. The FDA does not evaluate such products for efficacy, merely to make certain they are manufactured out of safe materials and that the bottle contains the ingredients listed on the label. Some users have claimed that products like the VitalErotic Shot do not work as advertised.

In light of the FDA’s investigation and other claims that these over-the-counter remedies are ineffective, a class action investigation has been launched to explore the possibility of legal action against the manufacturers of products like the VitalErotic Shot. Such a lawsuit could indicate that the products did not perform as advertised, or used misleading marketing practices, and seek compensation for allegedly false claims used in the labeling and marketing of these products.

If you used VitalErotic shots and was dissatisfied with the results, you may be entitled to compensation. You can start to explore your options by visiting the Sex Enhancement, Sexual Arousal Products Class Action Lawsuit Investigation. Here, you can enter information about your situation for a legal review by a trained expert with a background in this type of litigation. The initial consultation is completely free of charge, and from here you can receive additional guidance on the best steps to take in your exact situation.

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