Preparing Your Company For Good Manufacturing Practice (GMP) Inspections
The dietary supplement industry has faced uncertainty over how FDA Inspectors will enforce the new Good Manufacturing Practice (GMP) regulations (21 C.F.R. 111). GMP inspections began last year, and dietary supplement manufacturers can now look to inspection observations reports filed by FDA inspectors to prepare their companies in advance of GMP inspections.
Although the GMP regulations currently apply only to companies with more than 20 employees, the rules are set to expand to include smaller manufacturers soon. Steve Meyers, of NaturalProductsInsider.com recently prepared a good summary of FDA inspection observation reports filed within the past year. Here are the higlights:
- Procedures: Inspectors carefully analyze a company’s procedures to ensure that procedures are written, complete, and cover every element of the manufacturing process.
- Implementation of Procedures: Inspectors focus on how effectively each aspect of the company’s written procedures are being implemented.
- Cleanliness: Inspectors focus heavily on cleanliness of the facility, how materials are transported and stored, sanitation procedures, etc.
- Testing: Inspectors focus how effectively the company tests each phase of the manufacturing process, from identifying the quality of the raw materials to verifying the strength of the seal on the packaging.
- Design of Facility: Inspectors even focus on the overall design of the facility, including wither the design ensures proper sanitation, quality control procedures, etc.
Dannon's Costly Yogurt Claims
If you haven’t seen Jamie Lee Curtis in the commercials, you have seen 
the products in the yogurt section at the grocery store. “It Works Or Your Money Back!” is the guarantee that Dannon makes regarding the ability of Activia, its probiotic line of dairy products, to boost digestive system health and immunity. Now an Ohio judge has signed a settlement agreement (pdf) in which the company agreed to pay up to $45 million as part of a class action settlement.
Understanding Front-of-Package Violations: Why Warning Letters Are Sent to Industry
Ever wonder if what you say on your label or packaging could draw the attention of the FDA? It's always helpful to be able to learn from examples of what's unacceptable before you release your product packaging.
The FDA has a helpful chart that summarizes FDA warning letters for nutrition claims on packaging that provides great examples of what to avoid.
So if, for example, your product is intended for children under 2 years of age, you may want to study the chart to understand why the FDA issued multiple warning letters to companies making nutrition claims for products intended for children under 2 years of age.
Good News on Senator McCain's S.3002, the Dietary Supplement Safety Act?
The dietary supplement industry received good news when Senator John McCain recently backed away from a bill that would have given the FDA greater authority to regulate the industry. Senator Orin Hatch, who had been critical of the bill, thanked Senator McCain for withdrawing the bill.
Here's a copy of Senator Hatch's letter to Senator McCain: 
Dietary Supplement Manufacturers Encounter "New Drug" Labeling Pitfalls In FDA's Enforcement of Federal Food, Drug, and Cosmetic Act
Manufacturers of dietary supplements should continue to keep a wary eye toward the claims they make in their product labeling, in light of recent government action. Regulatory enforcement actions by the FDA, in association with the United States Attorney’s Office, highlight the risks associated with the manufacture and labeling of dietary supplements.
Recently, government ire was peaked when one dietary supplement manufacturer made broad labeling claims touting its products’ ability to diagnose, mitigate, treat, cure or prevent certain diseases (including diabetes, irritable bowel syndrome, gout, high blood pressure, heartburn and diarrhea).
According to the government, the maker’s claims made it subject to several FDCA provisions, including Section 343(r)(6), and corresponding requirements under the Code of Federal Regulations. Consequently, the claims reflected in the products’ respective labeling resulted in the “designation” of each as a “new drug,” triggering federal regulatory compliance relating to the maker’s submission, and subsequent government regulatory review, of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) or Investigational New Drug applications (INDs), for each product.
After each was designated a “new drug”, the following enforcement action was filed by the United States Attorney’s Office: United States v. Thao, et al (.pdf). Further, the “new drug” designation, and the resulting trigger of additional regulatory requirements, left the maker subject to charges stemming from several statutory violations leading to government claims of wire and mail fraud, money laundering and conspiracy.
The stakes associated with inaccurate or overreaching product labeling are high. Effective guidance through the labeling process, with the advice of counsel familiar with requirements under Federal law, is a must.
Competitors both guilty of false advertising
A recent case illustrated two important points in advertising:
- substantiate one’s advertising claims; and
- make sure your glass house is strong before casting stones at a competitor.
Schering-Plough sued Neutrogena (PDF) claiming that Neutrogena’s sunscreen ads falsely claimed to offer the “best line of sun sport protection.” The judge agreed because a graph on the product suggested that UVA and SPF were different measures, which was false.
Notably, the judge found it irrelevant that the false information pertained to both products. Schering-Plough’s victory was short lived, however, because the judge also found that it lacked sufficient support for its advertisement that its Coppertone sun screen provided better coverage than Neutrogena’s sun screen. It seems that Schering-Plough had not tested Neutrogena’s product.
It is important to remember that advertisements need to be accurate and to have backup for all claims made. As this case shows, it is also important to review one’s own advertisements before bringing claims that a competitor’s advertisements are false.
