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Adult Novelties
Sex Toys, Adult Toys, Marital Aids, Sexual Health and Pleasure Products

Sex Toy Classifications

If you have ever wondered why sex toys are legally referred to as adult novelties you are not alone as many people question why the word novelty is applied to something that has a specific sexual purpose. What it comes down to is the legal classification and for those companies in the United States this is determined by the U.S. Food and Drug Administration (FDA). Within the FDA is the Center for Devices & Radiological Health (CDRH) which is the specific center that does such classification approvals. In Europe sexual products are classified through the European Commission and in Canada it is done through Health Canada.

Under these legal definitions there are two main categories that a sexual product is typically labeled as; either as a medical device or a novelty. In order for a sexual product to be classified as a medical device it must pass through rigorous criteria and be demonstrated to provide a medical benefit. Manufacturers have to go through a vast amount of research, filling requirements, classification requirements, product testing and study. In addition, it is extremely expensive to have a device classified as a medical device and in some cases can cost millions of dollars. Because of these challenges, sex toy manufacturers most often label sexual products as novelties even when they are fully intended for sexual arousal and in some cases provide health benefits. It is important that if you decide that you wish to manufacture a sex toy you should consult legal representation to ensure that you are properly labeling and marketing your products.

In the U.S., Medical Devices are Classified in Three Main Classifications:

  • Class I (low to moderate risk): general controls
  • Class II (moderate to high risk): general controls and Special Controls
  • Class III (high risk): general controls and Premarket Approval (PMA)

In addition to classification as a medical device, those devices that require controls typically require a 510(k) submission to the FDA / CDRH based on the risks that the medical device poses. Class I and Class II may not always require such filings as there are many exceptions for these classes but that must be determined by the FDA. Examples of other certifications and testing: REACH, RoHS, and Prop 65. Sex toy are also regulated regarding shipping via exports, tariffs, customs fees, duties, and certifications. Depending on the manufacturer, some are labeled "for novelty use only," while others are registered but not approved by the FDA.

ISO Safety Standards

ISO Safety Standards In September 2021, the International Standards Organization (ISO) approved new safety standards (ISO 3533:2021) for the quality of sex toys. It is specifically for products that directly contact the genitals, anus, or both. It does not pertain to medical devices, cosmetics, lubricants, massage oils, and food supplements. There are still no required regulations in the United States for sex toys, but sex toy companies can volunteer to these standards.

Personal Lubricant Classifications

Personal lubricants have not always been seen as medical devices but are now seen as such and must be cleared by the FDA in order to sell them commercially. As lubricants enter the bloodstream their ingredients must now be tested by FDA laboratories to ensure that there are no adverse effects on humans and are classified as either a Class I or a Class II Medical Device.

The 5 FDA Classifications for Personal Lubricants-

  • LTZ (Class II Medical Device) - Condom With Nonoxynol-9 (Regulation # 884.5310)
  • KMJ (Class I Medical Device) - Lubricant, Patient (Regulation # 884.6375)
  • NUC (Class II Medical Device) - Lubricant, Personal (Regulation # 884.5300)
  • PEB (Class II Medical Device) - Lubricant, Personal, Gamete, Fertilization, and Embryo Compatible (Regulation # 884.5300)
  • MMS (Class I Medical Device) - Lubricant, Vaginal, Patient (Regulation # 880.6375)

The FDA 510(k) Clearance

Lubricant manufacturers are required to submit a premarket notification if they intend to sell their lubricants for commercial distribution. When a company does not abide by this law, the FDA will send warning letters will be forced to be removed from theirs and resellers sites and shelves. If this is not adhered to the lubricant company can also be taken to court over not having an FDA 510(k) approval.

It is important that if you decide that you wish to manufacture a lubricant you should consult legal representation to ensure that you are properly labeling and marketing your products.


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