Tag Archives: Food and Drug Administration (FDA)

Sweet Victory: Ninth Circuit Affirms Dismissal of Trader Joe’s Honey False Ad Suit

The Ninth Circuit affirmed the dismissal of a class-action lawsuit that alleged Trader Joe’s Manuka Honey product labeling was misleading. Trader Joe’s marketed its store brand Manuka honey as “100% New Zealand Manuka Honey” or “New Zealand Manuka Honey.” Plaintiffs claimed that these labels were misleading because the honey only consisted of between 57.3% and … Continue Reading

Changes to Google Ad Policy to Affect Pharmaceutical Industry; Requires Immediate Action to Paid Search Ads

Google has announced a new advertising policy for pharmaceutical companies that presents significant issues and dictates immediate changes.  Effective July 20, pharmaceutical companies can no longer run pharmaceutical ads in the so-called “Black Box Ad Format” – a format that had previously been approved by the FDA.  Instead, pharmaceutical companies will now have to run … Continue Reading

FDA Writes Prescription for Social Media for Drug and Device Companies

The FDA issued two draft guidance documents on social media last week. The first guidance pertains to product claims and risk information on platforms such as Twitter and Google's sponsored links, while the second guidance covers correcting misinformation that originates from independent third parties on the Internet and social media sites. The FDA has opened up a comment period and will be accepting comments until September 16, 2014.… Continue Reading

FDA to Drug Companies: We Are Watching – Even on Social Media

The FDA recently issued a warning to a Swiss drug company for failing to include on its Facebook page a product's risk information and limitations. Although this type of enforcement activity involving drugmaker conduct on social media has been rather uncommon, it is a stern reminder for companies that the FDA is monitoring activity, and that its marketing and advertising rules apply to product promotion over social media networks as well. For additional information on this story, read the latest post on our firm's Life Sciences Legal Update blog.… Continue Reading

FDA Makes Changes to Nutrition Facts Label

In order to provide consumers with increased information to make well-informed food choices, the FDA announced today a noteworthy overhaul in the presentation of the Nutrition Facts panel on packaged foods. Among the revisions are updates to the display, including font size changes and bolded text, new serving size and nutrient content calculations, and added sugar information. The changes will have implications for the advertising industry, presenting advertisers with the opportunity to capitalize on various nutrition claims. The FDA has invited feedback on the proposed changes and will be accepting comments for 90 days. For more information, please read the recent post on our Life Sciences Legal Update blog.… Continue Reading

Should Prescription Drug Risks Be Limited in TV Commercials? The FDA Wants Your Opinion

Our firm's LSHI Group reported on an announcement by the Food and Drug Administration (FDA) last week, asking for public input on a proposed research study concerning whether the risks presented in direct-to-consumer (DTC) prescription drug ads should be limited solely to risks that are considered "serious and actionable." While some say the current risk statements found in TV ads are too long and result in, among other things, reduced consumer comprehension, others believe the DTC ads do not provide enough risk information. The deadline for feedback is April 21, 2014. For more information, read the recent post on the Health Industry Washington Watch blog: http://www.healthindustrywashingtonwatch.com/2014/02/articles/regulatory-developments/fda-developments/coming-to-a-tv-near-you-fda-seeks-public-input-on-limiting-risks-presented-in-directtoconsumer-television-ads/… Continue Reading

FDA Knows Time Is Running Out on Internet and Social Media Guidance

In a recent interview published by Pharmalot, the Director of the FDA Office of Prescription Drug Promotion (OPDP), Thomas Abrams, indicated that the long-waited draft guidance on the promotion of medical products using the Internet and social media is forthcoming. According to Abrams: "The development and issuance of guidance for social media is among the highest of FDA's priorities." With other agencies issuing social media guidance over the past year (e.g., FTC, SEC), it is hard not to believe Abrams. However, some skepticism is warranted because the industry has been waiting for FDA's promises about forthcoming Internet-related guidance for almost two decades now...… Continue Reading

Faux Natural

Ice Cream maker BEN & JERRY’S confirmed that after receiving a request from the Center for Science in the Public Interest (CSWPI) all BEN & JERRY’S Ice Cream labels will no longer include the phrase “all natural.” The change, according to company spokespersons, will occur gradually, over time. The Food & Drug Administration (FDA) itself … Continue Reading

FDA Seeks to Understand Social Media

Earlier this month, the Food and Drug Administration (FDA) held public hearings to better understand the role of, and the risks associated with, the promotion and marketing of FDA-regulated products using the Internet and social media. The last such hearing of this kind (which focused solely on the Internet) was organized by the FDA in 1996; … Continue Reading

Cheerios – a Drug?

General Mills is the Food and Drug Administration’s ("FDA") latest target. In case you think that you misread the previous statement, General Mills—manufacturer of the popular cereal "Cheerios"—received a letter addressed to its Chairman from the FDA May 5 claiming that the FDA has reviewed various Cheerios labels and found they contain "serious violations" of federal … Continue Reading

No Cold Meds for Kids Under 4, Companies Say

Children under the age of 4 should not be given over-the-counter (OTC) cold remedies, according to new labeling being prepared by leading cold medicine manufacturers. The manufacturers of medicines sold under brands such as Dimetapp, Pediacare, Robitussin, Triaminic and Little Colds have agreed to voluntarily change their labels to state “do not use” for children … Continue Reading

Battle Over Baby Bottle Plastic Rages On

When it comes to the risk posed by bisphenol-A (BPA), the chemical used to make hardened plastic containers such as baby bottles, liners for canned goods, and other plastic items, government officials can’t seem to agree. In September, the National Toxicology Program (NTP), which is part of the National Institutes of Health, released a report … Continue Reading
LexBlog