Whether or not we offer sexual enhancement products is perhaps our most-asked question. The answer is a resounding; “No, sorry, we do not.” Natural herbal products that help promote and support sexual wellness have been given a bad name. In fact, the FDA, in 1989, stepped in and banned the sale of any products marketed as “aphrodisiacs.” They also stated that any claims on any marketing or packaging that claim to “arouse or increase sexual desire, or that it will improve sexual performance,” is automatically an aphrodisiac drug product.
We don’t make any claims that any of our products will do any of these things. What we do state here at Sextracts Sexual Wellness, is that a healthy lifestyle, coupled with specific sexy foods and herbs can help to increase your overall wellness. Therefore, that may help support overall sexual wellness as well. Since 1989, there have been a large number of studies conducted on various herbs, many of which were marketed as “herbal aphrodisiacs” up until 1989. Many of these studies are animal-only studies, but many of them included humans as well.
The results of these studies have provided overwhelming evidence that the topic of arousing or increasing sexual desire might not be as cut and dry as has been presented to the public. Sexual enhancement herbs as they’re typically called got a really bad name because of how they were marketed. But the industry is finally starting to recognize that there may actually be some foods and herbal products that can at least help support sexual wellness.
We can’t claim that any of our products cause sexual desire, but we can claim that our products can help to support healthy sexual desire.
That part is a no-brainer, really. If we’re feeling calm, free of anxiety, if we’re feeling confident and at our best, it doesn’t make sense to say that there’s no chance of performing better in the bedroom. Happier, healthier people can make for happier, healthier sex lives, and Sextracts Sexual Wellness products help to support healthy libido and healthy sexual desire.
It is never our intent to mislead anyone in relation to our sexual wellness products. We make it as clear as we can in all of our marketing and all of our packaging, that we are not claiming that any of our products will increase penis length, that any of our products will make you sexier to the opposite sex. We’re also not claiming that your sexual desire will be increased by using any of our products, or that any of them will “restore sexual vigor, potency, and performance.” We can report that countless customers have reported all kinds of positive effects when it comes to their sexuality, and we’re happy to report those here. We also report traditional and folk medicine uses for the products for educational and historical reasons. We don’t claim any of our products do any of the things that the literature states they have been used for, but we do offer that information to empower you to be as informed as possible when making any decisions on any of our sexual wellness products.
Also, every one of our natural herbal products and formulations are backed by science, as well as peer-reviewed studies. If we make any mention of “aphrodisiac” or “sexual enhancement”, it’s only in reporting what researchers and scientists have stated in their published studies. If there’s no science to back any of our products, we don’t offer them here at Sextracts Sexual Wellness products. And, the only times we use any questionable terminology is in order to accurately report the findings from the various studies we have researched extensively.
In addition, all of our products have been in interstate commerce before 1990. Why is this important? Because any products that were in the marketplace before 1990 are not subject to regulatory action. All of our products are not only GRAS products, all of the ingredients were introduced into the marketplace and interstate commerce before 1990.
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Sec. 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
(a) Any product that bears labeling claims that it will arouse or increase sexual desire, or that it will improve sexual performance, is an aphrodisiac drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, mandrake, methyltestosterone, minerals, nux vomica, Pega Palo, sarsaparilla, strychnine, testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are powerful hormones when administered internally and are not safe for use except under the supervision of a physician. There is a lack of adequate data to establish general recognition of the safety and effectiveness of any of these ingredients, or any other ingredient, for OTC use as an aphrodisiac. Labeling claims for aphrodisiacs for OTC use are either false, misleading, or unsupported by scientific data. The following claims are examples of some that have been made for aphrodisiac drug products for OTC use: “acts as an aphrodisiac;” “arouses or increases sexual desire and improves sexual performance;” “helps restore sexual vigor, potency, and performance;” “improves performance, staying power, and sexual potency;” and “builds virility and sexual potency.” Based on evidence currently available, any OTC drug product containing ingredients for use as an aphrodisiac cannot be generally recognized as safe and effective.
(b) Any OTC drug product that is labeled, represented, or prompted for use as an aphrodisiac is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act, (the act), for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the act.
(c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for OTC use as an aphrodisiac is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.
(d) After January 8, 1990, any such OTC drug product initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action.
[54 FR 28786, July 7, 1989]
