Todd Harrison & Erin Warren, Venable01.02.14
The dietary supplement industry in 2013 saw the continuance of old enforcement themes, escalation of ongoing actions and a continued deterioration of the scope of the permissible structure/function claim. This article touches on some of the most revealing topics of FDA enforcement over the past year.
In 2013, FDA upped the ante in regard to its issuance of Warning Letters, citing violations of current Good Manufacturing Practice (cGMP) requirements for dietary supplements. In all of 2012, FDA issued approximately 20 Warning Letters, citing dietary supplement cGMP violations. In comparison, from just January to September of 2013, more than 25 dietary supplement firms received Warning Letters referencing cGMP violations. Common citations included failure to establish specifications and failure to take proper steps to assure that component suppliers are meeting specifications.
In 2013, in particular, the agency underscored the responsibility of each firm releasing products into the marketplace, whether it manufactures the product itself or not, to know how manufacturing activities are performed and to verify that finished products meet specifications for identity, purity, strength and composition. This requirement essentially holds private label distributors liable for adulteration of a product as a result of cGMP violations, whether or not they are involved in the cGMP operation. As such, 2013 saw a significant rise in the number of dietary supplement distributors and marketers auditing their contract manufacturer’s facilities.
FDA also amplified its enforcement efforts against companies marketing dietary supplements containing synthetic botanicals in contravention of the agency’s July 2011 New Dietary Ingredient Draft Guidance. Essentially, the draft guidance stated that synthetic copies of botanical constituents are not dietary ingredients permitted for use in supplements. In what was an unexpected leapfrog of the federal rulemaking process, prior to finalization of the guidance, FDA began to enforce the “non-binding,” “Draft—Not for Implementation,” guidance in the spring of 2012 by sending Warning Letters to companies using the ingredient dimethylamylamine (DMAA), known by its common name geranium extract, in their dietary supplements.
In addition to continuing the Warning Letter trend, FDA escalated its enforcement of the draft guidance by initiating actions to seize and condemn 1,500 cases of supplements containing DMAA from a GNC warehouse in June 2013. After the actions were filed, however, GNC voluntarily agreed to destroy all DMAA-containing products remaining at the warehouses. In November 2013 the agency again seized more than $2 million worth of DMAA-containing products from Hi-Tech Pharmaceuticals. We expect 2014 to see both a continuation of FDA’s enforcement of its synthetic botanical policy, as well as the long-awaited finalization of the draft guidance.
Claims At Issue
As in previous years, FDA continued to battle, mostly in Warning Letters, what the agency believes are disease claims made for dietary supplements. Disease claims—those that claim to cure, treat or prevent disease—are impermissible for dietary supplements. While the general theme was the same in 2013, FDA began singing a different tune when it took a special interest in blood sugar and non-specific inflammation claims.
FDA issued at least 10 Warning Letters in 2013 to companies for making alleged disease claims correlating dietary supplements to inflammation. Moreover, more than 150 companies—many in the practitioner channel—also received warnings from FDA in the early months of 2013 demanding that the companies discontinue product claims related to inflammation. Based on these actions, the agency may very well consider any mention of “inflammation” a disease claim.
While inflammation, in some cases, is connected to well-recognized diseases (e.g., arthritis, pelvic inflammatory disease, etc.), it is also the cornerstone of the human body’s natural healing response. The body uses inflammation to respond to injury, infection or irritants like pollen and dust. In fact, it is the body’s primary mechanism for internal homeostasis, restoring normal structure and function to organs, tissues and cells.
Though the industry has long-recognized there is a gray area between an impermissible disease claim and a permissible structure/function claim when it comes to inflammation, 2013 saw a significant increase in the cited violations for inflammation claims thought by many to live unequivocally in the world of permissible structure/function claims.
These impermissible disease claims include: “Holm Oak (an ingredient in your product) … [a]nti-inflammatory … properties,” “supports … the body’s natural anti-inflammatory response,” “helps inflammation” and “reduces … inflammation.” Given these cited violations, it appears the agency made a concerted effort to enlarge the scope of impermissible inflammation claims in 2013 to include claims that dietary supplements modify or balance inflammatory responses generally, making such claims de facto drug claims.
Similarly, in June and July of 2013, FDA issued nine Warning Letters to companies marketing dietary supplements allegedly making diabetes-related disease claims. However, the claims were not diabetes-specific and, instead, largely centered on generic blood sugar claims like “lower blood sugar” and “sugar balancer.” It is well established that dietary ingredients such as cinnamon, chromium and fibers (e.g., Fenugreek seeds), among others, affect blood sugar in beneficial ways. As with inflammation claims, the agency appears to be demonizing the body’s normal physiological response to nutritional elements.
As we move into 2014, developing appropriate structure/function claims related to inflammation and blood sugar, without getting tangled in the impermissible disease claim web, will continue to be a challenge. FDA’s treatment of these two categories of claims as disease claims, and the subsequent classification of these products as unapproved new drugs rather than dietary supplements, serve to further reduce the dwindling pool of permissible claims available to those who wish to advertise their dietary supplement products.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
In 2013, FDA upped the ante in regard to its issuance of Warning Letters, citing violations of current Good Manufacturing Practice (cGMP) requirements for dietary supplements. In all of 2012, FDA issued approximately 20 Warning Letters, citing dietary supplement cGMP violations. In comparison, from just January to September of 2013, more than 25 dietary supplement firms received Warning Letters referencing cGMP violations. Common citations included failure to establish specifications and failure to take proper steps to assure that component suppliers are meeting specifications.
In 2013, in particular, the agency underscored the responsibility of each firm releasing products into the marketplace, whether it manufactures the product itself or not, to know how manufacturing activities are performed and to verify that finished products meet specifications for identity, purity, strength and composition. This requirement essentially holds private label distributors liable for adulteration of a product as a result of cGMP violations, whether or not they are involved in the cGMP operation. As such, 2013 saw a significant rise in the number of dietary supplement distributors and marketers auditing their contract manufacturer’s facilities.
FDA also amplified its enforcement efforts against companies marketing dietary supplements containing synthetic botanicals in contravention of the agency’s July 2011 New Dietary Ingredient Draft Guidance. Essentially, the draft guidance stated that synthetic copies of botanical constituents are not dietary ingredients permitted for use in supplements. In what was an unexpected leapfrog of the federal rulemaking process, prior to finalization of the guidance, FDA began to enforce the “non-binding,” “Draft—Not for Implementation,” guidance in the spring of 2012 by sending Warning Letters to companies using the ingredient dimethylamylamine (DMAA), known by its common name geranium extract, in their dietary supplements.
In addition to continuing the Warning Letter trend, FDA escalated its enforcement of the draft guidance by initiating actions to seize and condemn 1,500 cases of supplements containing DMAA from a GNC warehouse in June 2013. After the actions were filed, however, GNC voluntarily agreed to destroy all DMAA-containing products remaining at the warehouses. In November 2013 the agency again seized more than $2 million worth of DMAA-containing products from Hi-Tech Pharmaceuticals. We expect 2014 to see both a continuation of FDA’s enforcement of its synthetic botanical policy, as well as the long-awaited finalization of the draft guidance.
Claims At Issue
As in previous years, FDA continued to battle, mostly in Warning Letters, what the agency believes are disease claims made for dietary supplements. Disease claims—those that claim to cure, treat or prevent disease—are impermissible for dietary supplements. While the general theme was the same in 2013, FDA began singing a different tune when it took a special interest in blood sugar and non-specific inflammation claims.
FDA issued at least 10 Warning Letters in 2013 to companies for making alleged disease claims correlating dietary supplements to inflammation. Moreover, more than 150 companies—many in the practitioner channel—also received warnings from FDA in the early months of 2013 demanding that the companies discontinue product claims related to inflammation. Based on these actions, the agency may very well consider any mention of “inflammation” a disease claim.
While inflammation, in some cases, is connected to well-recognized diseases (e.g., arthritis, pelvic inflammatory disease, etc.), it is also the cornerstone of the human body’s natural healing response. The body uses inflammation to respond to injury, infection or irritants like pollen and dust. In fact, it is the body’s primary mechanism for internal homeostasis, restoring normal structure and function to organs, tissues and cells.
Though the industry has long-recognized there is a gray area between an impermissible disease claim and a permissible structure/function claim when it comes to inflammation, 2013 saw a significant increase in the cited violations for inflammation claims thought by many to live unequivocally in the world of permissible structure/function claims.
These impermissible disease claims include: “Holm Oak (an ingredient in your product) … [a]nti-inflammatory … properties,” “supports … the body’s natural anti-inflammatory response,” “helps inflammation” and “reduces … inflammation.” Given these cited violations, it appears the agency made a concerted effort to enlarge the scope of impermissible inflammation claims in 2013 to include claims that dietary supplements modify or balance inflammatory responses generally, making such claims de facto drug claims.
Similarly, in June and July of 2013, FDA issued nine Warning Letters to companies marketing dietary supplements allegedly making diabetes-related disease claims. However, the claims were not diabetes-specific and, instead, largely centered on generic blood sugar claims like “lower blood sugar” and “sugar balancer.” It is well established that dietary ingredients such as cinnamon, chromium and fibers (e.g., Fenugreek seeds), among others, affect blood sugar in beneficial ways. As with inflammation claims, the agency appears to be demonizing the body’s normal physiological response to nutritional elements.
As we move into 2014, developing appropriate structure/function claims related to inflammation and blood sugar, without getting tangled in the impermissible disease claim web, will continue to be a challenge. FDA’s treatment of these two categories of claims as disease claims, and the subsequent classification of these products as unapproved new drugs rather than dietary supplements, serve to further reduce the dwindling pool of permissible claims available to those who wish to advertise their dietary supplement products.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
