Regulation of OTC Dental Products and Practices (Part-5)
Over the past decade, there has been a prominent rise in the over-the-counter (OTC) use of oral health treatments, products, and medications. These practices offer several benefits such as easy accessibility, affordability, and convenience, as patients can buy them without consulting a dentist or relevant specialist. OTC products/treatments are particularly availed by patients who are afraid of visiting a dentist or have a busy schedule. The rise in the use of OTC oral health products can also be attributed to marketing tactics that include exaggerated claims, endorsements from celebrities and influencers, and attractive deals. Numerous oral care products are marketed to provide professional results from the comfort of one's own home. As a result, some individuals may opt for OTC products over professional treatment due to lower costs.
Where there is an influencer, there is a gullible person falling for their lies. In a country like India where celebs are put on a pedestal and these very celebs join the bandwagon of promoting at-home products. It has now become a race to the top for these companies to supply the ever-growing demand. Regulation of products and safety measures should be done before an unqualified individual is allowed to advertise for the same.Dr. Devika Shrivastava (Oral and Maxillofacial Surgeon)
Professional organizations have established strict guidelines for the testing and advertising of dental products and conduct rigorous screening to ensure that their ingredients are safe and effective for use without professional supervision. For instance, the American Dental Association (ADA) has set up rigorous testing protocols to approve dental products. In contrast, regulatory agencies overseeing OTC products in many developing countries are often weak, and even when regulations exist, they may not be implemented efficiently. As a result, these countries face a surge of unapproved OTC dental products flooding their markets.
In India, the IDA (Indian Dental Association) evaluates consumer dental products, including cosmetic agents, to determine if they are safe and effective in treating or preventing dental disease. The IDA Seal helps consumers make informed decisions about their purchases, and market research shows that the Seal influences their buying decisions. The products that have been approved by the Food Safety and Standards Authority (FSSAI) or the Indian Food and Drug Administration (FDA) for sale directly to consumers or through dental professionals are eligible for the IDA Seal. However, there are no specific guidelines for licensing OTC medicines, and non-prescription drugs are generally sold without regulation.
While several nations have clear laws and regulations for OTC drugs, India's Drugs and Cosmetics Rules do not define OTC drugs as a distinct category. To address this, Ahooja Committee called for the definition of OTC drugs in the rules and specific provisions for their regulation. The committee recommended developing an initial list of OTC drugs, regulating the switch from prescription to OTC drugs, overseeing the approval, distribution, sale, and advertising of new OTC drugs, and promoting self-care without compromising patient safety or increasing treatment costs.
While OTC oral products are generally safe if used correctly, they may contain ingredients that could cause adverse reactions if not used properly. Therefore, it is essential to deliver clear instructions to patients before recommending or prescribing any type of medication. Misuse of OTC products can lead to several concerns, including dependence on drugs, drug resistance, and delayed diagnosis of underlying conditions. Shockingly, a study found that 87% of OTC product labels lacked information regarding contraindications. Additionally, adverse effects were missing in 90% of labels, and 96% had no information about their use during pregnancy and breastfeeding. These inadequate instructions on product labels can potentially harm patients' health.
To summarize, OTC dental products can be a convenient and affordable way to tackle dental issues, it is crucial that any new dental products introduced to the market have scientific evidence to back up their effectiveness and claims. It is therefore imperative to regulate the production, sale, and distribution of OTC products to ensure that patients are not harmed by using these products.
References:
Marathe PA, Kamat SK, Tripathi RK, Raut SB, Khatri NP. Over-the-counter medicines: Global perspective and Indian scenario. J Postgrad Med. 2020 Jan-Mar;66(1):28-34.
Dicksit DD, Ramachandra SS, Tawfiq O, Kalyan C G. Over-the-counter Dental Products: Need for Regulation. Indian J Oral Health Res 2015;1:44-7.
Aloyouny A. Y, Alromaih Y, Alhassoun R. Over-The-Counter Oral Hygiene Products Misuse: A Case Report. Biosc. Biotech. Res. Comm. 2021;14(4).
https://www.ida.org.in/AboutUs/Details/IDASeal
http://www.pharmabiz.com/NewsDetails.aspx?aid=143333&sid=1