Will I Go to Jail for Nutritional Supplement Scams?

If you're involved in the nutritional supplement industry, you may be wondering about the potential legal risks - especially when it comes to criminal liability. At Spodek Law Group, we understand these concerns and have extensive experience defending clients against allegations of nutritional supplement fraud and related charges.The short answer is: yes, you could potentially face jail time for certain types of nutritional supplement scams or violations. However, the specifics depend heavily on the nature of the alleged misconduct and how prosecutors choose to pursue the case. With skilled legal representation, there may be opportunities to avoid criminal charges or minimize penalties.Let's take a closer look at the legal landscape surrounding nutritional supplements and potential criminal exposure:

Overview of Nutritional Supplement Regulation

Nutritional supplements occupy a somewhat unique regulatory space. They are generally regulated as "foods" rather than drugs under the Food, Drug, and Cosmetic Act (FDCA). However, there are also supplement-specific rules under the Dietary Supplement Health and Education Act of 1994 (DSHEA).Some key points to understand:

• Supplements are defined as products taken by mouth that contain "dietary ingredients" like vitamins, minerals, herbs, amino acids, etc.
• They are intended to supplement the diet, not treat or cure diseases
• Manufacturers don't need FDA approval before selling dietary supplements
• However, companies are responsible for ensuring their products are safe and properly labeled

While this regulatory framework provides some flexibility, it also creates opportunities for bad actors to exploit. And in recent years, we've seen increased scrutiny and enforcement actions targeting the supplement industry.

Potential Criminal Charges Related to Supplements

There are a number of ways supplement companies or individuals could face criminal liability, including:

• Introducing adulterated or misbranded supplements into interstate commerce (21 U.S.C. § 331)
• Making false or misleading claims about a supplement's benefits (21 U.S.C. § 331(a))
• Failing to register manufacturing facilities with the FDA (21 U.S.C. § 350d)
• Selling products containing undisclosed drugs or other prohibited ingredients

Prosecutors may pursue these as misdemeanors or felonies depending on the circumstances. Felony convictions can potentially result in years of imprisonment and hefty fines.For example, in United States v. Bello, executives of a supplement company were sentenced to prison terms ranging from 13-40 months for conspiring to sell products containing undisclosed drugs.

Recent Enforcement Trends

We've observed several key trends in supplement-related prosecutions:

1. Increased focus on Covid-19 claims: The FDA has aggressively targeted companies making unproven claims about supplements preventing or treating Covid-19. Criminal charges have followed in some cases.
2. Crackdown on "tainted" supplements: There's been a major push to prosecute companies selling supplements containing undisclosed drugs, especially in categories like weight loss and sexual enhancement products.
3. Executive liability: We're seeing more cases where company executives and employees are individually charged, not just the corporate entities.
4. Conspiracy charges: Prosecutors often bring conspiracy charges to cast a wider net and increase potential penalties.
5. Cross-agency cooperation: There's increased coordination between agencies like the FDA, FTC, and DOJ in building cases.

Defending Against Criminal Supplement Charges

If you're facing potential criminal liability related to nutritional supplements, having an experienced defense team is critical. At Spodek Law Group, we have a proven track record of successfully defending clients in this complex area.Some key defense strategies we employ include:

• Challenging the government's evidence and testing procedures
• Arguing lack of intent or knowledge of wrongdoing
• Negotiating plea agreements to avoid felony charges
• Pursuing pretrial diversion programs where appropriate
• Mounting aggressive trial defenses when necessary

We understand the nuances of supplement regulations and how to effectively counter the government's case. Our goal is always to achieve the best possible outcome for our clients, whether that means getting charges dismissed, negotiating a favorable plea, or prevailing at trial.

Case Study: Defending Against Adulteration Charges

To illustrate our approach, consider this anonymized case study:Our client, a mid-sized supplement manufacturer, was facing felony charges for allegedly selling products containing undisclosed prescription drugs. The FDA had conducted a raid and claimed their testing showed the presence of sibutramine (a weight loss drug) in several supplement batches.Our defense strategy involved:

1. Retaining independent experts to review and challenge the FDA's testing methods
2. Demonstrating our client's robust quality control procedures
3. Arguing that any contamination was inadvertent and unknown to company leadership
4. Negotiating with prosecutors to narrow the scope of charges

Ultimately, we were able to secure a misdemeanor plea agreement for the company with no individual charges against executives. This allowed the business to continue operating and avoided any prison time for company leadership.

Proactive Compliance Measures

Of course, the best defense is avoiding criminal exposure in the first place. We strongly advise supplement companies to implement robust compliance programs, including:

• Thorough ingredient testing and quality control
• Careful review of all marketing claims
• Clear SOPs for GMP compliance
• Regular audits and assessments
• Employee training on regulatory requirements

Our team can help design and implement these preventative measures to reduce your legal risks.

Conclusion

While criminal prosecutions in the supplement industry are on the rise, skilled legal counsel can make a tremendous difference in the outcome of your case. At Spodek Law Group, we have the experience and expertise to mount an aggressive defense and protect your interests.If you're facing potential criminal charges related to nutritional supplements - or want to ensure your business is fully compliant - don't hesitate to reach out. Call us today at 212-300-5196 for a confidential consultation. Our attorneys are standing by to help safeguard your future.Remember, early intervention is key in these cases. The sooner you involve experienced counsel, the more options we'll have to resolve the situation favorably. Don't wait until charges are filed to seek help.