Johnson & Johnson baby powder is banned globally but will not discontinue in India; the Indian Drug regulatory authority is silent.

Johnson & Johnson baby powder is banned globally but will not discontinue in India; the Indian Drug regulatory authority is silent.

What’s going on

Beginning in the following year, Johnson & Johnson says it will stop selling its talc-based baby powder everywhere. In 2020, J&J discontinued selling the powder in the U.S.

What’s at stake

For years, concerns about the safety of J&J’s talc-based powder have been raised, mostly due to a possible connection to cancer. Numerous lawsuits have been brought against the pharmaceutical company.

Next steps

J&J is currently the target of lawsuits. The business is still selling its cornstarch powder, which is now accessible in the U.S.

Johnson & Johnson refuses to remove contentious baby powder from stores in India.
Experts have questioned the company’s decision to hold off on pulling the allegedly cancer-causing asbestos-containing medicine, but the Indian pharma regulator has remained silent.

Johnson & Johnson, a U.S. firm, does not plan to remove the talc-based baby powder off the Indian market despite litigation alleging that it includes a chemical that causes cancer.

According to a J&J spokeswoman, “We will work with merchants to keep the product on the shelf until our supply of talc-based powder runs out.”
Further confirming that there are no intentions to discontinue the talc-based powder, a J&J executive.

Due to allegations that their talcum powder was tainted with asbestos, which causes cancer, J&J is facing tens of thousands of lawsuits.

No recall is in effect. We are still committed to the product’s security. We’ll keep producing it through the first quarter of the next year. We will then stop producing,” the boss declared.

The executive responded, “It’s a worldwide decision,” when asked if J&J’s decision in India resulted from regulatory action.

Regarding J&J’s choice, inquiries submitted to the Drug Controller General of India went unanswered.

Last year, the D.C.G.I. and the Central Drugs Standard Control Organization (C.D.S.C.O.) were summoned by the National Commission of Protection for Child Rights (N.C.P.C.R.) due to the lack of standardization in the testing procedures used to check for the presence of formaldehyde and asbestos, two substances known to promote the development of cancer in humans, in J&J’s baby shampoo and talcum powder.

Recall of an item

Experts questioned J&J about their decision to keep the product on the market and why it should be supplied to Indians, given that talc-based powder is not popular and is the subject of legal action. The manufacturer discontinued the product’s U.S. sales more than two years ago.

“The corporation is slowly putting its adopted strategy in the western half of the world into practice in India.

Why should a product be sold if manufacturing of it is being stopped? Why not just recall it? Official inquired.

According to C.D.S.C.O. regulations, any batch of items sold in India must be voluntarily or legally recalled if it does not fulfill quality standards.

According to an affidavit from the C.D.S.C.O., the Bureau of Indian Standards has authority over the question of testing procedures for formaldehyde and asbestos in newborn care items.

In the affidavit examined, C.D.S.C.O. stated that cosmetics in the completed form must adhere to the Bureau of Indian Standards criteria as set forth from time to time. This is following rule 150 A of the 1945 Drugs and Cosmetics Rules.

Transitional period

J&J said on August 11 that it would discontinue producing talc-based baby powder internationally in 2023 and switch to a baby powder line entirely made of cornstarch.

The company switched to baby powder based on cornstarch in the US, Canada, and the U.K. two years ago. It is gradually implementing this in other regions of the world, including India. The corporation reported global revenues of $94 billion in 2021.

“Johnson’s baby powder made from corn starch is available in several nations. We’re thrilled to be able to provide Johnson’s baby powder, which is based on corn starch, to additional customers worldwide, the representative said.

The demand for talc, according to an executive, has decreased.

The C.E.O. stated, “The Johnson & Johnson baby powder will continue, but it will no longer be a talc-based product, but rather a cornstarch-based product.”

According to the J&J spokesman, the company assesses and optimizes its portfolio to place the company in the best possible position for long-term success.

According to the spokesman, “this move will help streamline our product offerings, deliver sustainable innovation, and satisfy the demands of our consumers, customers, and changing global trends.”

Talc, the softest known mineral created by magnesium, silicon, and oxygen, serves as the base for talcum-based baby powder. Using a food ingredient, corn starch is created. Because of the bigger particle size, it is considered a safer alternative to talc for baby powder.

Due to the fact that many talc mines are situated in regions where asbestos naturally exists, some talc contains asbestos. Research has connected asbestos to ovarian and lung cancer.

The business has been the subject of lawsuits alleging that certain women’s ovarian cancer may be brought on by the continuous use of their talcum powder.
N.C.P.C.R. chairperson Priyank Kanoongo applauded the business’ choice to use corn starch instead of talc.

The rights of children in India are comparable to those in the U.S. It’s a smart approach, but there are also concerns about infant shampoo. The organization ought to focus on that as well, Kanoongo suggested.

According to the All-India Organization of Chemists and Druggists, J&J will control India’s $15 billion baby product market by 2022. (A.I.O.C.D.).

“When it comes to the market for baby talcum products in India, Johnson & Johnson still has the dominant position. According to Rajiv Singhal, general secretary of the A.I.O.C.D., it currently holds between 60 and 70 percent of the market share in the nation.

The J&J executive responded, “We don’t reveal sales data,” when asked about overall sales of baby talc powder and the effect of this change in India.

In recent years, J&J has been at the center of debates concerning its goods. In 2013, the Maharashtra medicines regulator revoked the company’s license after discovering that the plant producing the powder used ethylene oxide, a carcinogen.

The Indian medicines regulator required J&J to compensate patients in 2018 for marketing subpar hip implants. Formaldehyde was found in Johnson’s infant shampoo samples that underwent testing in February 2019. However, the Gujarat regulator later gave the product the go-ahead.

Last year, J&J announced that it was voluntarily recalling all five sunscreen products after discovering that some samples contained very low quantities of benzene, a substance that, when exposed repeatedly, can cause cancer.

The silky, white Johnson & Johnson baby powder has come under fire for its safety and is intended for both newborns and adults. Talc, widely used in cosmetics in the U.S., is the cause for concern.

Numerous lawsuits alleging a connection between talc-based baby powder and cancer and respiratory issues are still pending and number in the hundreds. J&J was also compelled to make billions of dollars in settlement payments to those who claimed the powder was to blame for their cancer.

According to the allegations, the talc used in the infamous bathroom staple may be contaminated with asbestos, a known carcinogen, which, when used over an extended period of time, can cause cancer or other health problems.

In a press release, Johnson & Johnson stated that switching to solely cornstarch powder “will assist streamline our product options” and satisfy consumer demands. The business defended the older talc powder’s safety as well.

J&J stated, “Our stance on the security of our cosmetic talc remains unaltered. We completely support the decades of independent scientific research conducted by medical professionals from all around the world that demonstrates the safety, lack of asbestos, and non-carcinogenicity of talc-based Johnson’s Baby Powder.

According to “decades of independent scientific testing,” which J&J cited in March, the cosmetic talc used in baby powder is harmless and doesn’t cause cancer.

The business cited sizable cohort research published in the Journal of the American Medical Association and found no statistically significant link between ovarian cancer and baby powder use, including certain varieties containing talc.

Smaller research and some batch testing of J&J’s baby powder and other talc-containing cosmetics have suggested that talc contamination is a real, albeit variable, concern. Here is what we now know about talc’s potential health effects.

What is talc

Talc is a soft mineral that may be crushed into talcum powder, a fine powder used in cosmetics such as blush, eye shadow, and baby powder.
For years, people have used it to remove moisture from the skin or make your makeup look less cakey.

Johnson & Johnson Baby Products: Risks for babies

Johnson & Johnson baby powder became a staple in parents’ toolkits for avoiding dampness in children’s diapers. The Agency for Toxic Substances and Disease Registry states that professionals have long known that talc-containing products may contain asbestos, a known carcinogen (ATSDR).

Although talc is only a naturally occurring mineral, it can become contaminated with asbestos since talc mines are usually located adjacent to asbestos in the Earth. Talc mineral samples frequently contain asbestos material when analyzed. Although scientists have long known that asbestos causes cancer, they have purposely kept the public in the dark about the science underlying the link between talc and asbestos.

The product’s safety has been upheld by the company for years, and it was reiterated on Thursday. It issued a statement saying, “Our opinion on the safety of our cosmetic talc remains unaltered.” J&J affirmed that their talc-based JOHNSON’S® Baby Powder is safe, does not contain asbestos, and does not cause cancer by citing decades of independent scientific examination by medical professionals.

Cancers Linked to Asbestos

Talc is not thought to present a significant risk to consumers on its own. However, consumers may be more likely to get certain types of cancer linked to asbestos if the talc contains asbestos fibers (which happens frequently with talc). Mesothelioma, a cancer of the membranes that line the chest or belly, is brought on by asbestos, according to the National Cancer Institute. In addition, asbestos exposure can cause mesothelioma of the testicles, ovarian cancer, laryngeal cancer, peritoneal cancer, and lung cancer. These tumors are extremely dangerous and frequently fatal.

Asbestos, what about it?

Talc and underground asbestos are closely related. The term “asbestos” refers to several distinct minerals mined for industrial use across numerous sectors. It is a known carcinogen, and even though it is allowed in the U.S., use has dramatically decreased since studies started to uncover dangers in the 1970s.

Asbestos can result in lung cancer and other issues, while the risk varies depending on exposure levels and other variables. Workers in the mining or construction industries are more likely to be exposed to asbestos.

A significant majority of the cosmetic goods evaluated in the past that contained talc were examined by several agencies, including the U.S. Food and Drug Administration, contained asbestos. Several cosmetic companies were recalled by the F.D.A. in 2019 due to asbestos exposure, including a significant amount of Johnson & Johnson’s baby powder.

Talc is a restricted material in the European Union due to the possibility of asbestos contamination.

Most health complaints and legal actions against talc-based baby powder center on ovarian cancer cases, most likely as a result of vaginal use. Many people have used baby powder in this manner over the years or even been told that it is hygienic, as part of a larger marketing movement that urged people (women especially) to be “fresh.”

Talcum powder and other “vaginal therapies” should not be used, according to the American College of Obstetricians and Gynecologists, as they can irritate the area.
Is asbestos present in all talc powder?

The million-dollar question remains about how frequently talc-based goods like J&J’s original baby powder might contain asbestos.

The F.D.A. started checking samples of talc-containing cosmetic items for the presence of asbestos in 2018. As a result of such tests, numerous goods have been recalled. Batches of eye shadow, blush, and baby powder have all been recalled in the past due to possible asbestos contamination.

Over the years, it was discovered that some batches of cosmetics were asbestos-contaminated while others were not.

This raises the possibility of a production lot or batch problem, which several cosmetic testing organizations have identified as a potential hazard, similar to when traces of benzene were discovered in some sunscreen lots but not others of the same brand.

The only J&J baby powder now offered for sale in the U.S. is their cornstarch baby powder, which doesn’t include talc. Talc is no longer included in many other firms’ baby powder formulae, but since it is legally legal, other businesses can still sell talc powder.

What do the studies reveal?

Although there is no conclusive evidence connecting Johnson & Johnson’s talc-based baby powder to ovarian cancer, the scientific community’s opinion on the safety of talc when used cosmetically is still unclear.

According to the American Cancer Society, research in both humans and lab animals has yielded mixed results, making it unclear whether talc-containing products (which don’t include asbestos) could nevertheless increase the risk for cancer.

The International Agency for Research on Cancer of the World Health Organization, which does not categorize talc as generally carcinogenic but does categorize talc use in genital areas as “potentially carcinogenic to humans,” serves as the foundation for the society’s conclusions.

However, there is ample evidence connecting asbestos exposure to an increased risk of cancer: the National Cancer Institute includes ovarian cancer as one of the diseases connected to asbestos.

There was no “statistically significant” link between baby powder use in the vaginal area and ovarian cancer, according to a sizable study involving thousands of women and published in the Journal of the American Medical Association in 2020. Notably, and as noted by the U.S.A.

Today, the study did not distinguish between baby powders with talc bases and those with alternative bases, such as the cornstarch Johnson & Johnson powder that is currently offered in the U.S.

In conclusion? Because cosmetics are subject to ambiguous regulations, there is always a risk of product contamination even after years of usage of everyday things containing trace amounts or exposure to high concentrations from work-related risks.

What is the status of J&J’s legal actions?

Johnson & Johnson has used a strategy known as the “Texas two-step” to get around the lawsuits. It split off a portion of its business into a different state, renamed it LTL Management, transferred all the lawsuits to the new business, and then filed for bankruptcy, which, according to the law, halted the lawsuits and prevented the alleged victims from obtaining Johnson & Johnson’s assets because its LTL arm was declared bankrupt.

LTL is “ready to cooperate with claimants’ lawyers and the mediator to reach a fair and efficient resolution as mandated by the Bankruptcy Court,” according to a statement from Johnson & Johnson. Additionally, the business declared that it “unwaveringly and persistently supported early resolution for the benefit of all parties.”

The company’s history with the powder has gained another, darker dimension, according to a Bloomberg report: Following a recent trial, Bloomberg obtained unsealed court records that revealed that in a J&J-funded study conducted more than 50 years ago, approximately a dozen prisoners received injections of asbestos to compare the cancer-causing mineral with talc. According to the report, Black men made up the majority of the prisoners.

In a statement, Johnson & Johnson said, “We deeply regret the circumstances under which these studies were carried out, and in no way do they reflect the values or practices we employ today.” The company also pointed out that other businesses and organizations conducting medical research, including the U.S. government, engaged in similar behavior.

The discomfort around Johnson & Johnson’s baby powder lingers, despite the fact that the negative aspects of medical and cosmetics trials in the U.S. are not unique to one firm, especially in light of some reports that claim the company was aware of the potential for risk from the beginning.

Executives at the corporation, according to media reports from 2018 by Reuters and The New York Times, have been aware of potential asbestos contamination since the 1970s. Johnson & Johnson refuted this and cited a statement in which it was claimed that the questioned tests had been shown to be erroneous.

Talc is still deemed safe by J&J.

Johnson & Johnson insists that the product is safe to use and does not present any health hazards despite the recent global suspension.

The results of scientific investigations on Johnson’s Baby Powder with talc are conflicting. According to certain research, women who take the product frequently have a higher risk of developing ovarian cancer. Other research has not identified a risk.

The statement read, “Our position on the safety of our cosmetic talc remains unaltered.” We firmly support the decades of independent scientific research by medical professionals from throughout the world that demonstrates the safety, lack of asbestos, and non-carcinogenicity of talc-based Johnson’s Baby Powder.

Other decisions have been made by the courts.

Johnson & Johnson sought to have a Missouri state court decision from 2018 that awarded 22 women a total of $2.1 billion in damages brought on by talc products overturned by the U.S. Supreme Court in 2021, but the appeal was denied.

The New York State Supreme Court, however, overturned a 2019 ruling earlier this year that had awarded a woman $120 million in damages for ovarian cancer she said was brought on by talc laced with asbestos in the Johnson & Johnson product she used.

When Johnson & Johnson discontinued the distribution of talc-based powder in North America in 2020 because of the onslaught of legal suits, the company also asserted that its product was safe, attributing the change to dwindling demand and “misinformation.”

The U.S. Food and Drug Administration, which found minute amounts of asbestos in baby powder samples taken in 2019, also played a role in the suspension.
The J&J litigation’s future is uncertain.

A federal judge in New Jersey eventually authorized the bankruptcy plan early in 2022 after much discussion.

Nearly all of the ongoing cases have been put on hold due to the bankruptcy petition, which would involve a trust fund with an estimated $3 billion in value.

Plaintiff attorneys are still contesting J&J’s reorganization plan in a federal appellate court, and Congress is currently investigating it. The contentious bankruptcy method, which became legal 30 years ago, has only been employed a few times by other businesses seeking to reduce their exposure to significant liabilities.

If the bankruptcy file is not allowed, this most recent decision to stop all sales of talc-based goods might have an impact on the outcomes of subsequent legal proceedings.

edited and proofread by nikita sharma