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USDA Organic & GMO Counsel

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Detentions & Holds

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Labels, Claims & Ingredients

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Fractional In-House Counsel

Detentions & Holds

Regulatory Due Diligence

Labels

Claims & Ingredients

Contracts: Draft & Review

Fractional In-House Counsel

Is your business dealing with issues from the USDA Organic & GMO Counsel? Organic and non-Genetically Modified Organisms (GMOs) marketing has been around for a long time. However, not all of it is truthful or legal, and the federal government has the right to regulate these claims. The United States Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) regulates organic products and GMO labeling. If you want to market food or supplements as “organic” or “non-GMO,” you will need to comply with AMS regulations and policy.

It is imperative that you have a strong understanding of how these regulations work and how they apply—or do not apply—to your business. Failure to comply can lead to government enforcement and private litigation. You do not have to go it alone. Hiring an attorney experienced with organic and AMS enforcement actions can help you navigate the system and stay in the organic and non-GMO markets. At MyFDALawyers.com, PC, our USDA organic and GMO counsel has the knowledge, skills, and experience you can trust. Contact us today for a confidential consultation.

USDA Organic & GMO Counsel – Organic Products

The AMS regulates organic products under its National Organic Program (NOP). And, while the NOP has the authority to take enforcement action (along with the California Organic Program), the program is actually administered primarily through private third-party organic certifiers.

To produce and sell a product as organic in the United States, the manufacturers and handlers of the product must be certified by an NOP-approved third-party certifier. These certifiers charge fees, often proportionally to product sales.

The certifier will determine whether product labels, production, and cultivation meet NOP’s stringent organic standards. See 7 C.F.R. § 205. If you have any specific questions or concerns about whether or not your product qualifies, and how exactly you can prove that it qualifies, an FDA lawyer with USDA organic/GMO labeling experience can help.

There are four kinds of
organic products

“100% Organic”
Products that contain only organic ingredients, excluding water. These products can bear the USDA Organic Seal. To qualify for this label, every ingredient and all processing aids used must be certified organic under the National Organic Program (NOP). That means that no synthetic additives, GMOs, or prohibited substances may be present. The production must follow strict USDA guidelines, including detailed documentation and certification by an accredited agent. It is the highest level of organic labeling. As the standard is so high, it is most commonly found on single-ingredient items like fruits, vegetables, or organic flours. Still, it can also apply to multi-ingredient products when all components meet the very tight 100 percent organic standards.

“Organic”
Products that contain only organic ingredients, in addition to NOP-approved ingredients that are not available in organic form. These products can also bear the USDA Organic Seal. To qualify, at least 95 percent of the ingredients must be certified organic. Further, the remaining 5 percent must be on the USDA’s approved list, and they cannot be commercially available in organic form. No GMOs, sewage sludge, or irradiation can be used at any stage. Further, these products must still be certified by a USDA-accredited certifying agent. Some of the most common examples include baked goods, soups, or packaged snacks that use both organic and limited non-organic components.

“Made with Organic”
Products that contain at least 70% organic ingredients. These products may not bear the USDA Organic Seal. With that being said, they can include the phrase “made with organic [specified ingredients]” on the front panel, such as “made with organic oats and raisins.” The remaining non-organic ingredients must still comply with strict federal product guidelines, including being free from GMOs and not producing prohibited practices. These products must also be certified by an accredited certifying agent. The category “made with organic” is most often used by companies seeking to highlight meaningful organic content while using limited non-organic ingredients.

“Less than 70% Organic”
Products that contain less than 70% organic ingredients. These products cannot use the USDA Organic Seal and can only note the organic status of ingredients in the product’s ingredient list. These products cannot use the USDA Organic Seal and can only note the organic status of ingredients in the product’s ingredient list. For example, an ingredient list may state “organic honey” or “organic oats,” but no organic claim may appear on the main display panel. Certification is not required, but the use of the term “organic” must still comply with USDA’s more general truth-in-labeling standards.

gmo Labeling

The AMS also administers the law controlling GMO labeling. Congress gave the AMS authority over GMO labeling in 2016 with the passage of the National Bioengineered Food Disclosure Law.

Congress did this, in part, to create a unified national standard and prevent states from developing multiple GMO (and possibly contradictory) labeling requirements.

The new law has changed the terminology from Genetically Modified Organisms (GMOs) to bioengineered (BE). Under the new rule, foods regulated by the Food and Drug Administration (FDA) must disclose the presence of BE ingredients to consumers.

This can be accomplished on the label with words, AMS-approved symbols, or digitally (e.g., text message, scans). Organic products are exempt from BE disclosure requirements.

terms to Familiarize Yourself With

If your business or organization is involved in organic products or non-GMO products, it is imperative that you have a strong, comprehensive understanding of product labeling and marketing regulations. There are some key industry-specific terms to know. Learning these terms will help you understand the organic and BE systems:

  • NOP – The National Organic Program, a part of USDA-AMS. This program oversees all organic products, product labeling, and national policy. Officers enforce organic requirements and regulate third-party certifiers. The NOP also maintains the National List of Allowed and Prohibited Substances. It sets the standards for what can and cannot be used in organic production.
  • Organic –An agricultural product that complies with the requirements of the Organic Foods Production Act of 1990 and the regulations promulgated by AMS. These products must be produced without synthetic fertilizers, genetic engineering, irradiation, or sewage sludge.
  • Bioengineered –Food that contains genetic material that has been modified through in vitro rDNA techniques and that could not be obtained through conventional breeding or found in nature. Such foods are subject to disclosure requirements under the National Bioengineered Food Disclosure Standard.
  • Certifying Agent – A private third-party that NOP has accredited to certify production or handling operations as properly organic. These agents are responsible for reviewing applications, conducting inspections, and issuing organic certificates in compliance with NOP regulations.

How an FDA Attorney Can Help

The USDA regulations for the labeling and marketing of organics and GMOs are complicated. It is normal to have a lot of questions about your rights and your responsibilities. The right legal representation can make the difference. Indeed, an attorney experienced in AMS policy and enforcement is your ally and advocate for entering and staying in the organic and BE markets. Bill Senior and Rick D. Quinn have decades of experience helping businesses and entrepreneurs navigate the full range of FDA issues, including those related to organic regulations and/or GMO regulations. More specifically, our USDA and GMO counsel is ready to:

  • Hear your story and answer questions about your case.
  • Gather and prepare all of the required supporting documentation.
  • Help you with any USDA organic/GMO filings and correspondence.
  • Take whatever legal action is needed to help you overcome any challenges.

Your certifying agent can help you through the process of becoming NOP compliant. However, it is important to understand that although you are paying the certifier, they remain an agent of the government. The certifier is your inspector – not your ally in an investigation. They are not on your side, and when there are serious allegations, they will work with AMS to attack your reputation. You need an attorney as your advocate, to not only file your documents – but to defend your operation, reputation, and profits. A proactive approach is key: Call us today if you are facing an AMS investigation, suspension action, or fear that you may soon face one.