J&J confirms widely expanded contact lens recall

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http://news.yahoo.com/s/nm/20101201/hl_nm/us_jandj_recall

Johnson & Johnson, which has been beset by product recalls, on Wednesday confirmed that it recalled nearly five times as many contact lenses as the 100,000 boxes it announced in August due to eye stinging.

J&J said that in late October the recall of its 1 Day Acuvue TruEye lenses, which took place primarily in Japan, was expanded to a total of about 492,000 boxes.

The New Jersey-based global healthcare conglomerate, which claims to be striving for greater transparency in the wake of a series of image-damaging recalls of over-the-counter medicines, said it announced the expanded recall by press release only in Japan, where some 75 percent of the affected product was sold, leaving J&J investors largely in the dark.

The company is already under criminal and congressional investigation in the United States over a series of massive recalls of such products as Children's Tylenol, Motrin and Benadryl due to quality control lapses and other problems.

[laconicsax]

1. Imagine if supplements were regulated...

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2. they are regulated

http://www.fda.gov/food/dietarysupplements/consumerinformation/ucm110417.htm

What is FDA's oversight responsibility for dietary supplements?

Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.

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3. From your own link:

What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.
Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.
Also, manufacturers need to register themselves pursuant to the http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/default.htm">Bioterrorism Act with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. (See http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/RegulationsLaws/ucm079496.htm">Current Good Manufacturing Practices (CGMPs) - Dietary Supplements) These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.

Must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?

The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.
There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information, see http://www.fda.gov/Food/DietarySupplements/ucm109764.htm">new dietary ingredients.

Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?

Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.

Who has the responsibility for ensuring that a dietary supplement is safe?

By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. However, manufacturers and distributors of dietary supplements must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products that are reported to them directly. FDA is able to evaluate these reports and any other adverse event information reported directly to us by healthcare providers or consumers to identify early signals that a product may present safety risks to consumers. You can find more information on reporting adverse events associated with the use of dietary supplements at http://www.fda.gov/Food/DietarySupplements/Alerts/ucm111110.htm">Dietary Supplements - Adverse Event Reporting.

Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?

No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information. For more information, see http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm">claims that can be made for dietary supplements

That's some regulation! The FDA doesn't evaluate whether a supplement is safe, doesn't validate efficacy claims so long as a disclaimer is on the label, and there's an enormous loophole when it comes to determining if an ingredient is "new."

Do you want to try again?

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4. they are regulated

If they supplements are unsafe, they can be recalled. The same is true for Johnson and Johnson products.

Safety, not lack of efficacy, caused the J and J products to be recalled.