The US Department of Justice announced on December 26, 2019 that a New York federal district court had permanently enjoined several New York companies from “distributing dietary supplements because the supplements were adulterated and misbranded.” Adulteration and misbranding violate the federal Food, Drug, and Cosmetic Act (FD&C Act). The defendants were:
- ABH Nature’s Products, Inc.,
- ABH Pharma, Inc.,
- StockNutra.com, Inc. (together, “ABH”)
The owner, Mohammed Jahirul Islam (“Islam”) was also enjoined.
Companies that manufacture and market dietary supplements should review FDA compliance requirements with experienced FDA compliance attorneys before beginning operation to reduce the risk of FDA enforcement actions. The review will examine FDA definitions and regulations such as what constitutes misbranding and adulteration and when products may be classified as new drugs. New drugs require significant scientific research before the drugs will be approved.
The defendants in New York were given 15 days to destroy the supply of dietary supplements that were in the defendants’ “possession, custody, and control.” The defendants were also informed that before they could start manufacturing or distributing any more dietary supplements they would be required to “implement several consumer safety measures.” These safety measures include employing an independent professional to inspect the facilities and certifying that the problems have been corrected and that the companies and owner had “implemented current good manufacturing practices.” The defendants were also ordered to hire a labeling expert to ensure that the product label claims complied with the relevant laws and regulations. The federal court order was part of a consent decree. The defendants did agree fairly quickly, just about a month after the date of the initial complaint to the consent decree and the permanent injunction. The federal court approved the consent decree and then entered the injunction.
FDA enforcement actions often include, as in this case, working with the DOJ to ensure that the manufacture of dietary supplements complies with food safety laws and properly describes the ingredients. The Assistant Attorney General for the Civil Division of the DOJ said that the injunction shows the DOJ’s commitment to protecting the public from dietary supplements that are adulterated and misbranded.
The allegations in the DOJ complaint based on FDA investigations
Makers of products that are labeled dietary supplements must make sure the products are safe for consumption and that the labels do not mislead consumers.
The injunction is based on a complaint that was filed with the DOJ at the request of the FDA on November 21, 2019. The complaint asserted that the owner and companies “manufactured, prepared, labeled, packed, held, and distributed dietary supplements under conditions that failed to comply with current good manufacturing practice regulations.”
The specific complaints focused on allegations by the FDA that FDA observed key deviations from current good manufacturing practices – during inspections of the facilities. These defects included:
- Failing to verify that some of the dietary supplements “met the product’s specifications for identity, purity, strength, and composition”
- Failing “to implement a production system that ensured the quality of the supplements”
- Failing “to include necessary information in its production records”
- Failing “to properly review and investigate a consumer complaint”
The November 2019 complaint also asserted that the manufacturing companies and owners further violated the FD&C Act by “distributing unapproved and misbranded “new drugs” into interstate commerce”
As an example, the complaint alleges that the manufactures claimed on the product labels that the dietary supplements “could be used to treat such medical conditions as cancer, heart disease, HIV and AIDS, even though the FDA had not approved those products for such purported uses.” FDA is not aware of any published studies or investigations showing that the manufacturer’s products are “generally recognized as safe and effective for any use.”
Laws and regulations that govern dietary supplements
The National Institutes of Health sates that “according to the 2012 National Health Interview Survey, almost 18 percent of adults and about 5 percent of children used dietary supplements in 2012.”
FDA concerns about this broad use of dietary supplements have led to aggressive review of the claims of manufacturers and investigations into these products.
There are various laws and regulations that govern dietary supplements. The best course of action is to discuss the laws and regulations with experienced dietary supplement attorneys who can explain when dietary supplements and marketing may result in FDA oversight.
Dietary supplement laws
FDA regulates dietary supplements and dietary ingredients. The laws that govern FDA oversight include the FD&C Act and the Dietary Supplement Health and Education Act of 1994 (DSHEA). These laws provide that the makers and distributors of dietary supplements/ingredients cannot market adulterated or misbranded products. The manufacturers and distributors are responsible for examining the safety of the products and making sure the product labels are accurate before marketing and selling the products. FDA has the authority to issue FDA warning letters and seek legal enforcement, with the help of the US DOJ, to enforce the governing laws and regulations.
DSHEA defines dietary supplements as:
- Containing “one or more vitamins, minerals, herbs or other botanicals, amino acids, or other dietary ingredients”
- “Intended to be taken by mouth as a pill, capsule, tablet, powder, or liquid”
- Being identified on the label as dietary supplements
Dietary supplements include children’s vitamins, weight-loss products, sports nutrition, and other products. Nutritionally, for example, supplements include:
- Vitamin D nutrients for adults and children who may have limited exposure to sunlight
- Iron and folic acid for women who are pregnant or capable of becoming pregnant.
Many products that claim to have essential nutrients do not have any proven medical benefits.
Dietary supplement regulations
According to an article in the Pew Charitable Trusts:
- Dietary supplements are not regulated as drugs. Dietary supplements are regulated as a category of food.
- Because dietary supplements are not regulated as drugs, manufacturers do not need premarket approval that the supplements are safe an effective
- Manufacturers of dietary supplements also do not need to inform FDA that the product is new “unless the manufacturers intend to make a structure/function claim about it” or “unless the product contains a new dietary ingredient (NDI)—such as a vitamin, mineral, or herb that was not on the U.S. market before Oct. 15, 1994.”
Makers of dietary supplements that do contain an NDI must notify the FDA 75 days before the product is introduced – showing evidence that the product is reasonably expected to be safe.
Definition of “adulterated”
- When manufacturers fail to submit a proper NDI notification when required or
- “If FDA determines that there is insufficient history of use or evidence that the NDI can reasonably be expected to be safe.”
- Dietary supplements may also be considered to be “adulterated” if the supplements:
- “present a significant or unreasonable risk of illness or injury under their recommended use, the label’s indication, ordinary conditions of use”
- “pose an imminent hazard to public health or safety” or
- Have “been prepared, packed, or held under conditions that do not meet current manufacturing regulations.”
Definition of “misbranded”
Dietary supplements are considered misbranded foods if “the labeling is false or misleading.”
Misbranding also includes failure of the label to:
- Identify the name and quantity of each ingredient
- Make clear that the product as a dietary supplement
Additionally, if the dietary ingredient is an herb or botanical, the manufacturer should identify which plant the ingredients are derived from
Enforcement actions when dietary supplements are deemed adulterated or misbranded
If the FDA concludes the dietary supplement program is adulterated or misbranded, it can:
- Issue a mandatory recall
- Suspend a manufacturer’s registration
- Detain a product identified during an inspection
- Block an imported product’s entry
- Send an FDA warning letter which sets for the violations and the requirements for compliance and what happens if the manufacturer fails to comply
- Use judicial actions such as:
- Seeking an injunction against a manufacturer
- Filing a prosecution action against the manufacturer
- File a seizure action against the adulterated and misbranded products
FDA can enact rules to regulate or restrict the use of certain ingredients.
What claims by dietary supplements makers are generally permissible
All claims about a dietary supplement should be reviewed with an experienced dietary supplement attorney. In addition to potentially violating the FD&C Act, and DSHEA, the Federal Trade Commission may also intervene if claims are false or misleading.
Generally (exceptions usually apply); online advertising, print advertising, and product labels can make truthful claims about the ingredients and benefits of a dietary supplement. Generally, the claims cannot include statements that the supplement “will diagnose, treat, cure, or prevent any disease.” Products that make these medical claims will be regulated as drugs. The products will be defined as adulterated and misbranded because the products are not approved drugs.
The main claims that are generally permissible, according to FDA, by dietary supplement manufacturers are:
- “Structure/function claims describe the effect of a dietary ingredient on the structure or function of the body or characterize the actions by which the ingredient maintains such structure or function.” Statements like “fiber maintains bowel regularity” or “calcium builds strong bones” are examples of structure/function claims. No FDA preapproval is required for these structure/function claims. Nor is scientific evidence required. However, the manufacturers of dietary supplements that makes these claim must be able to substantiate the claims in a report and submit the report to FDA with 30 days after the products are marketed.
- Health claims. Health claims do require FDA approval and are contingent on FDA’s determination that there is “significant scientific agreement” to support claims between dietary ingredients and diseases or related health conditions. A common example of a dietary supplement health claim is “Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.”
- Qualified health claims. Manufacturers can make these limited claims without the “significant scientific agreement” provision. To make these qualified health claims, manufacturers must petition FDA. A key FDA concern is that the claim should not mislead consumers. An example of a qualified health claim is, “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
- Nutrient content claims. These claims must be authorized though FDA regulations. Examples include “sugar free” or “high in vitamin C.”
FDA will seek to enforce the FD&C Act when manufacturers make claims that indicate dietary supplements are misbranded or adulterated. Through an investigation of the company site and through a review of online marketing claims, FDA may also determine that products are new drugs which require rigorous scientific review. Some dietary supplement claims may be permissible provided the claims comply with FDA regulations.
FDA is not able to physically inspect every manufacturer’s site. FDA cannot inspect every online site or marketing material. Still, manufacturers and distributors of dietary supplements should review all compliance issues with experienced dietary supplement attorneys. The consequences for violations can include being enjoined from developing, distributing, and marketing the dietary supplements; the closure of the business, finds, and penalties.
Contact Cohen Healthcare Law Group, PC for legal counsel on healthcare transactions, regulatory compliance, and FDA and FTC law. Our experienced healthcare & FDA attorneys advise healthcare companies and healthcare providers ranging from medical centers, to integrative and functional medicine practices, cosmetics and supplement companies, and medical device manufacturers.