For years people try to overcome nail biting by using bitter substances, products that are supposed to function as nail biting deterrents. These nail biting deterrent products contain Denatonium Benzoate also known as Birex©, or sucrose octaacetate. Basically it sounds logical that using a bitter substance to deter a person or a child from biting his nails will work. The truth is that according to the FDA (U.S Food and Drug Administration) these products are not only potentially dangerous and might harm your health, but also simply don’t have any proof that they actually do what they claim to do. Before you buy or use any nail biting deterrent product we advise you to read the following document written by the FDA. If you are looking for a true solution for nail biting, bitter or hot products is not the answer, according to the FDA it isn’t safe nor effective. Anyone who has ever tried using nail biting products knows that the bitter taste is something that you are easily getting used to and by no means has the power to overcome the nail biting impulse. Usually within less than a week, nail biters will return to bite their nails despite the bitter or hot products applied on their nails and cuticles. In order to stop the nail biting impulse more drastic measures need to be taken. Dental Nail biting deterrent devices block the front teeth from doing any damage to the nails and cuticles, after 2 months of continues use the nail biting urge is suppressed, chronic nail biting (Onychophagia) is a severe condition that needs severe intervention in order to be stopped, it can be done by using dental Nail biting deterrent devices which will enable you to stop biting your nails click to learn more…

The following is a quotation from the Code of Federal Regulations Title 21, Volume 5, by the FDA (Food and Drug Administration): ” [Code of Federal Regulations]

[Title 21, Volume 5]

[Revised as of April 1, 2020]

[CITE: 21CFR310.536]

TITLE 21–FOOD AND DRUGSCHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER D – DRUGS FOR HUMAN USE

PART 310 — NEW DRUGS

Subpart E – Requirements for Specific New Drugs or Devices

Sec. 310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.

(a) Denatonium benzoate and sucrose octaacetate have been present in OTC nailbiting and thumbsucking deterrent drug products. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these and any other ingredients (e.g., cayenne pepper) for OTC use as a nailbiting or thumbsucking deterrent. Based on evidence currently available, any OTC drug product containing ingredients offered for use as a nailbiting or thumbsucking deterrent cannot be generally recognized as safe and effective.

(b) Any OTC drug product that is labeled, represented, and promoted as a nailbiting or thumbsucking deterrent 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 application or abbreviated 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 or abbreviated 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 a nailbiting or thumbsucking deterrent 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 March 2, 1994, 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.

[58 FR 46754, Sept. 2, 1993]” source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=310.536