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The Other Shoe Drops on Just Mayo
September 2, 2015By Ricardo Carvajal –
FDA issued a warning letter to Hampton Creek alleging that its Just Mayo products are misbranded, in part because they purport to be a food governed by a standard of identity – namely, mayonnaise – that the products fail to meet. This alleged violation was at the heart of a lawsuit filed against Hampton Creek last year by Unilever, which Unilever subsequently dropped so that Hampton Creek could “address its label directly with industry groups and appropriate regulatory authorities” (see Unilever’s press release here). To the extent any such efforts were undertaken by Hampton Creek, they appear to have been unsuccessful in warding off FDA’s warning letter. The focus now shifts to whether the company can devise a way to resolve FDA’s concerns without having to make changes so extensive as to adversely affect the brand’s early success.
In addition to expressing concerns with the product names and logo, FDA found that the labels include unauthorized use of nutrient content and health claims. These alleged violations, coupled with the alleged violation of the standard of identity, can be expected to serve as grist for the plaintiffs’ bar. The take-away for start-ups is fairly straightforward: in a highly regulated sector such as food, success will quickly draw attention to regulatory non-compliance, and good intentions can’t be counted on to keep the hounds at bay.
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- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 2024
- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized